Libi-Gel female viagra

Drug Companies after Female Viagra

2008-02-28T14:31:00.000-08:00

Jean Toth's experience with Intrinsa -- Procter & Gamble's first-in-its-class testosterone skin patch -- has changed her life. She lost her sexual desire after going through menopause.

"The very first time they showed me how to put it on -- I put it on in their offices -- and on my way home, it was like, 'Yes! We are gonna have fun tonight!' " said Toth, a 56-year-old tax analyst from Cleveland.

Toth was taking the drug as part of Procter & Gamble's clinical trials. The company had hoped to win preliminary approval today for widespread sales from a Food and Drug Administration advisory committee. But the group said that more study is needed to ensure it is safe for long-term use.

A study published in the Journal of the American Medical Association estimates that 43 percent of women, like Toth, suffer from what is now called female sexual dysfunction -- including women who have lost sexual desire after menopause.

http://abcnews.go.com/WNT/story?id=298462

link

Bremelanotide for Female sexual dysfunction

2008-02-28T13:28:00.000-08:00

Bremelanotide drug for female is evolved after a long research and speculation. There are different drugs to treat male sexual disorders but there are no successful drugs for combating female sexual dysfunction. Many drugs are being manufactured for women sexual problems but failed to overcome the stress and tension, long working hours, tiredness, emotional problems and family burden, which affects women’s sexual urge and interest because it is link to the brain. Female sexual excitement wholly depends on female brains and its function.

It was a great challenge for medicine and drugs’ manufacturer to bring a drug, which can effectively work in females’ brains and initiate sexual stimulation. Bremalenotide, PT-141 drug for female sexual dysfunction is successfully evolved after long research and speculation. It is manufactured by employing Platin technology. Platin Technology is the application of American drugs and pharmaceutical company who took real challenge to bring out the wonderful drug, Bremalanotide, PTI-141. Some other new drugs for 2007 are januvia, adipex, , byetta, slimona and avodart.

link

Anti-depressant aphprdisiac for women

2008-02-28T13:14:00.000-08:00

TRIALS have begun on a sex drug that works directly on the pleasure zones of a woman�s brain to restore flagging libido.

If successful, flibanserin � developed by the German pharmaceutical company Boehringer Ingelheim � could become the �female Viagra�.

Its effect was discovered by accident when it was being tested as an anti-depressant. Participants in the trials reported that their depression was no better but that they had experienced a boost in sexual desire.

The company is conducting four trials on 5,000 women in 220 locations and hopes for approval from the US Food and Drug Administration in 2009.

The company is not yet sure exactly how flibanserin works, but Dr Charles de Wet, Boehringer Ingelheim�s medical director for the UK, said: �As many as two out of every 10 women describe some degree of decreased sexual desire. Female sexual dysfunction is not just related to blood flow, but also affected by stimulation of certain brain areas dealing with sexual stimuli.�

link

Libigel

2008-02-28T13:12:00.000-08:00

The drug--a form of testosterone called LibiGel that's rubbed into the upper arm--is at least two years away from pharmacy shelves. But Lincolnshire-based BioSante Pharmaceuticals helped sponsor a meeting of sex experts last week, seeking to convince them the company's on the right track.

Some are betting that a pill similar to an antidepressant could get there first. Boehringer Ingelheim Pharmaceuticals presented data at the same meeting showing that its drug, flibanserin, was significantly better than a sugar pill at improving the sex lives of women distressed over a loss of libido.

Lack of desire is typically women's most common sexual complaint, and drug companies have been racing to offer a medical solution. The issue was a central topic at the meeting of the International Society for the Study of Women's Sexual Health, which ended Sunday.

link

Testosterone for Women's Libido

2008-02-10T10:39:00.000-08:00

A testosterone gel, Paulsen says, could restore libido and reestablish the pre-menopausal balance between testosterone and estradiol. It could be especially beneficial to women who have had their ovaries surgically removed and lose even the small amounts of testosterone that ovaries produce after menopause. This population "is particularly susceptible to symptoms attributable to the loss of hormone production, such as hot flashes and loss of libido," he says.

Currently, the only option postmenopausal women have for boosting testosterone is off-label use of products developed for men, says Sheryl Kingsberg, chief of Behavioral Medicine at University Hospitals Case Medical Center in Cleveland, Ohio. "We know that it works -- not for everybody -- but it works," she says. "And we know that about 20% of all prescriptions for testosterone are for women."

Aphrodisiac Testosterone Libigel

2008-01-30T12:43:00.000-08:00

The promotion of testosterone as a female aphrodisiac was delayed for 50 years because the social conservatism of American physicians and of the society as a whole during the 1940s and 1950s could not accommodate public encouragement of sexual fulfillment as a therapeutic goal for all adults. It is seldom noted that the work of the pioneering sexologists of the first half of the twentieth century, including that of the controversial Alfred Kinsey, was intended to save marriages that were imperiled by sexual frustration. The most ardent testosterone therapist of the early 1940s, a University of Georgia gynecologist named Robert B. Greenblatt, implanted testosterone propionate pellets into women for precisely this purpose. As he described this strategy in 1943: "Many married women volunteered the information that their loss of sexual desire led to marital discord. Following pellet implantation there was a return of coital pleasure which often terminated in orgasm. A reawakened interest on the part of the husband usually followed and husband and wife once more fell in love." (11)

LibiGel drug a female viagra

2008-01-28T08:33:00.001-08:00

LibiGel drug a female viagra by BioSante to cure hypoactive sexual desire disorder.
University of Virginia is testing a new drug called LibiGel that can boost the libido of women who have lost interest in sex. This will greatly benefit women who are diagnosed with hypoactive sexual desire disorder, a medical condition which is believed to affect one third of american women.
In the coming months, BioSante Pharmaceuticals Inc proposed to offer the LibiGel drug to women as a miracle cure.
In their phase 2 of testing the LibiGel safety and efficiency, women who have had Ovariectomies, or surgical menopause were tested and 283 percent increase of satisfying sexual encounters for the women taking the LibiGel drug.
LibiGel is packaged in a pump bottle. The woman can rub a small dot of this gel into the skin of her upper arm.
In the next 24 hours, the gel's testosterone is absorbed by her bloodstream, boosting her energy and libido.
Here is a miracle cure for women in the form of LibiGel - a female viagra by BioSante

Female Sexual Dysfunction

2008-01-11T12:41:00.001-08:00

Concepts of female sexual dysfunction are controversial, particularly those based on biological causes. The American Psychological Association (APA) classifies female sexual problems as mental disorders: loss of sexual desire or arousal, discomfort during intercourse, diminished blood flow to the vagina, trauma-related aversion to sex, and the inability to achieve orgasm.

BioSante Pharmaceuticals LibiGel Study Protocol Finalized

2008-01-11T12:24:00.000-08:00

BioSante Pharmaceuticals has started its Phase III safety study of LibiGel for the treatment of female sexual dysfunction (FSD).

The study protocol was finalized after meetings with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III.

The randomized, double-blind, placebo-controlled, multicenter study will evaluate the cardiovascular risk of using testosterone in 2,400–3,100 women for 12 months, a key preapproval concern of the FDA, BioSante said.

BioSante also will conduct two six-month Phase III efficacy trials, one of which has begun. The company expects to start the other trial shortly.

A New Sex Enhancer for Women?

2008-01-05T11:53:00.000-08:00

A new salve, which is rubbed into the upper arm and absorbed by the skin, and apparently increases female sex drive may soon be on the market in the United States. Libi-gel, called a new 'female viagra,' offers hope for women who find thier sex drive and ability to reach orgasm isn't what it used to be.

Female Viagra Sex Salve?

2008-01-05T11:50:00.000-08:00

Libigel- a new ointment to enhance female sex drive! Looks like women are about to get a sexual dysfunction drug all thier own. Reported to cause an increase in sex drive within twenty-four hours of application, Libigel, which is being hailed as a "female viagra" may soon hit the market. The product is a testosterone gel which is rubbed into the upper arm and absorbed through the skin.

Female Sex Patch On Sale in Europe

2008-01-02T12:58:00.000-08:00

Britain's National Health Service has approved a patch that is claimed to help women regain their sex drive and treat female sexual dysfunction. The BBC earlier reported on the product's pending approval.

Intrinsa is the first treatment for treating female sexual dysfunction, and is available only by prescription for women who have had an early menopause because of surgery. It uses a female-specific form of testosterone. Although testosterone is often considered a male hormone, women also produce it in the ovaries. and a lack of it is thought to cause at least some cases of female sexual dysfunction.

Intrinsa has not been approved for use in the U.S. Reportedly regulators there had concerns about the safety of Intrinsa.

Doctors said there was no quick fix for low sex drive or female sexual dysfunction, and medical treatment was just one part of the therapy. And they emphasized that Intrinsa should not be seen as some kind of Viagra for women.

About a million women in the UK have had an early menopause because of surgery to remove their ovaries during hysterectomy for conditions such as heavy bleeding and pelvic pain, according to Procter and Gamble, the maker of the Intrinsa patch.

Another company, BioSante. has created a product called LibiGel, which an article in CNNMoney describes as "a metered-dose testosterone gel that's rubbed into the shoulder." This product is not yet on the market; it should soon enter Phase 3 safety trials. The company is looking to get approval for LibiGel to treat female sexual dysfunction in women who have entered menopause after having their ovaries surgically removed.

According to BioSante's CEO, a woman's natural testosterone levels drop by half right after surgery, which causes a "drop in desire and sexual activity." BioSante is hoping that LibiGel will find use for women with female sexual dysfunction who've reached menpause through aging, rather than surgery.

The CNNMoney article quotes an analyst as saying that he hasn't heard if P&G will reapply to get Intrinsa approved in the U.S.

http://libigelfemaleviagra.blogspot.com/2008/01/biosante-pharmaceuticals-libigel-study.html

Viagra-Like Drug for Women

2008-01-02T12:48:00.000-08:00

LibiGel comes in a pump bottle. The woman rubs the small dot of gel into the skin of her upper arm. Over the next 24 hours, the gel's testosterone seeps into her bloodstream, boosting her energy and libido.

Clayton, who is running the clinical trial at UVa, said the drug is better than previous testosterone treatments because it keeps levels of the chemical constant, much like naturally occurring testosterone.

"I expect this will work," she said.

In its second-phase clinical trials at 17 institutions, LibiGel led to a 283 percent increase of satisfying sexual encounters for the women taking the drug.

"A lot of women have this problem, but unfortunately they've been largely ignored by pharmaceutical companies," said BioSante's chief executive, Stephen M. Simes. "It's not fair that women have no drugs, while men have many."

Sexual Dysfunction in Women Causes and Treatments

2008-01-02T12:44:00.000-08:00

There are many problems that can keep a woman from enjoying sex. They include

* Lack of sexual desire
* Inability to become aroused
* Lack of orgasm, or sexual climax
* Painful intercourse

These problems may have physical or psychological causes. Physical causes may include conditions like diabetes, heart disease, nerve disorders or hormone problems. Some drugs can also affect desire and function. Psychological causes may include work-related stress and anxiety. They may also include depression or concerns about marriage or relationship problems. For some women, the problem results from past sexual trauma.

Occasional problems with sexual function are common. If problems last more than a few months or cause distress for you or your partner, you should see your healthcare provider.

Female Sexual Dysfunction: Evaluation and Treatment

2008-01-02T12:41:00.000-08:00

Female sexual dysfunction can be subdivided into desire, arousal, orgasmic and sexual pain disorders. Sexual pain disorders include dyspareunia and vaginismus.2

Estimates of the number of women who have sexual dysfunction range from 19 to 50 percent in "normal" outpatient populations3-6 and increase to 68 to 75 percent when sexual dissatisfaction or problems (not dysfunctional in nature) are included.5,

[Pharmacological treatment of female sexual disfunction

2008-01-02T12:32:00.000-08:00

The prevalence of sexual dysfunctions is approximately 40% in the female population. The disorders affecting sexual desire are the most common sexual dysfunctions encountered in women. Whereas recent studies have demonstrated clear influences of hormones on sexual dysfunctions, no pharmacological treatment has been approved for that indication. We will review here several pharmacological treatment strategies proposed in case of sexual dysfunction, underlying the fact that they are effective only to treat specific cases of sexual disorders but cannot replace the sex therapies.

Media Hypes PT-141 as Female Aphrodisiac of the Century

2008-01-02T12:28:00.000-08:00

There is nothing really new in the development of the possible sexual enhancement drug PT-141 – which has been hipped as being a powerful sexual enhancer for women – but there has been a media frenzy of stories, watched carefully by seniors citizens, on the possible aphrodisiac of the 21st Century. The only real news is that clinical trials are progressing but it is probably years from being available.

Sexual Dysfunction in Women

2008-01-02T12:26:00.000-08:00

Female sexual dysfunction has long been considered a taboo subject yet women's sexuality is now openly discussed and portrayed on television, in magazines, and on the internet.

Women's interest in sex and responses to sexual stimulation vary widely. Although most women's sexual responsiveness peaks in the late 30s and early 40s, a woman can have satisfying sexual experiences throughout her life.

Female sexual dysfunction describes women who are indifferent or hostile to sexual intercourse, who may have no response to advances of a sexual nature or stimulation, or who are unable to attain orgasm during sexual intercourse.

Female Sex Cream in Testing Phase

2008-01-02T12:17:00.000-08:00

A 2004 clinical study of LibiGel showed that the drug "increased the number of satisfying sexual events by 238 percent," from 2.1 to 7.1 events per month. If the drug never makes it to market, guys will be forced to hold out hope for something more along the lines of this. Which, you know, might be interesting. To some people.

BioSante receives $3.5 million payment under Bradley Pharma licensing deal

2008-01-02T12:14:00.000-08:00

'We look forward to a full year of marketing in 2008 and expect that Elestrin sales will increase as prescribing physicians become more familiar with it,' the company said, adding, 'With about $30 million in cash, we actively are working on our LibiGel Phase III development program.'
Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women.

Move over Men - Viagra for Women

2008-01-02T12:11:00.000-08:00

The University of Virginia in Charlottesville is currently testing LibiGel, an ointment designed to boost women's libido the same way Viagra does for men: Aiding sufferers of hypoactive sexual desire disorder that affects 1/3 of American women.

UVa, along with 99 other institutions, are testing the drug in hopes that it will eventually be available to women complaining of a low sex drive. 25 women ages 30 to 65 are taking part in the national study.

BioSante, an Illinois based drug company, says that this problem is experienced by many woman and has been "largely been ignored by the pharmeceutical companies". In its clinical trials at 17 institutions, Women's sexual satisfaction increased 283%

LibiGel video on YouTube

2008-01-02T12:00:00.001-08:00

Libi-Gel video now available on YouTube.

Female Sexual Enhancers

2008-01-02T11:10:00.001-08:00

With the advent of Viagra and the inescapable marketing push that followed the drug's release, the ability for men to speak up about their sexual problems has become easier. Now women are increasingly doing the same. Research studies show that as many as 43% of women experience sexual dysfunction at some point in their lives. Sexual dysfunction simply implies persistent or recurrent problems encountered in one or more of the stages of sexual response. For some women it may mean experiencing poor libido, or lack of sex drive. For others, it may mean an inability to become aroused or maintain arousal during sexual activity and impeding the ability to reach orgasm.

Female Sexual Enhancers

2008-01-02T11:10:00.000-08:00

Couples that "Play" Together, Stay Together!

2008-01-02T11:05:00.000-08:00

Doctors and relationship counselors agree a healthy sex life is a vital part of your overall physical and emotional well being. Unfortunately, many women are shy or feel embarrassed about saying anything when their natural desires for sex diminish.

Health Benefits of Orgasm

2008-01-02T11:01:00.000-08:00

Studies have found that sexual activity and orgasm in particular have major health benefits. Sex and orgasm are two of the greatest and best- kept health secrets around, so what's not to love about SEX?

* The act of sex produces several chemical hormones in the brain, including endorphins, which are responsible for your cheerful mood during and after sex.
* Right before orgasm, oxytocin is produced, which is the brain's natural chemical counterpart to morphine. Estrogen is also created, easing menstrual pains. Therefore, sex is the best and easiest painkiller!
* Studies reveal that frequent sex benefits the skin by stimulating the production of collagen and increasing the hormone progesterone, which is known to fight acne.
* Sex strengthens the immune system, saturating the bloodstream with antibodies that fight infections.
* Sexual orgasms provide the ultimate relaxation, sleep, and stress reduction.
* Engaging in a half hour of sex burns about 200 calories!

Provestra Female Libido Enhancement

2008-01-02T10:57:00.000-08:00

Is your intimate life on the back burner? Provestra™ is the safe, gentle way to discover or to re-ignite the desire, the excitement and the sexual responses that make sex wonderful and rewarding. With Provestra™, intimacy is at the top of your priority list, with the heat turned up!

Provestra™ addresses the top women's sexual health concerns:

* Increases libido or even restores lack of sex drive
* Improves levels of excitement during foreplay
* Benefits blood flow and engorgement of the clitoris
* Intensifies sexual sensation
* Speeds arousal and time to climax
* Strengthens orgasm, and increases likelihood of multiple orgasm
* Creates more frequent interest in, and enjoyment of sex

http://www.provestra.com/?a=mrk&t=estravildirect&c=0

phase III trial for Libigel, female viagrahttp://www.blogger.com/img/gl.link.gif

2008-01-02T10:17:00.000-08:00

"Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD
)," said Stephen M. Simes, president and chief executive officer of BioSante.

"We are encouraged by the clinically significant improvement in sexual events with LibiGel treatment in the Phase II study," said Michael C. Snabes, MD, PhD, a reproductive endocrinologist and Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology and BioSante's key clinical development consultant. "Since there are no medications approved by the FDA for the treatment of this common disorder, there is significant demand by patients and their physicians. We are hopeful that if and when LibiGel is approved by the FDA that LibiGel treatment will be able to improve the sex lives of women with low sexual desire and activity."

"We are pleased to be moving into Phase III clinical development of LibiGel. Female sexual dysfunction is underserved by the pharmaceutical industry today. LibiGel may help address this unmet medical need. We believe two Phase III safety and efficacy trials plus one year of safety data are the essential requirements for submission and approval by the FDA of a new drug application (NDA)," said Stephen M. Simes. "With the initiation of this Phase III LibiGel trial and our recent FDA approval of Elestrin[TM] (estradiol gel), this is a very exciting time for BioSante," he added.

BioSante Pharmaceuticals to Present LibiGel® at International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting

2008-01-02T10:00:00.000-08:00

About LibiGel®
LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.

According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm.

BioSante's hormone product portfolio
In addition to LibiGel, BioSante recently received FDA approval for Elestrin™ (estradiol gel), a fast-drying gel formulation of bio-identical estradiol, in the treatment of moderate to severe vasomotor symptoms (hot flashes) in menopausal women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes. Elestrin will be launched in mid-2007 by Bradley Pharmaceuticals, Inc., under a marketing agreement between BioSante and Bradley.

http://www.biosantepharma.com/newshtml/07/022107_pr.html

BioSante presents validation records for LibiGel

2008-01-02T09:58:00.000-08:00

As per FDA published guidance for patient reported outcome (PRO) studies, the pivotal efficacy studies of LibiGel require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. BioSante has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire.

BioSante worked with FDA's division of reproductive and urologic products and followed the FDA's guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of sexual events and desire (ISED) was able to differentiate between women with hypoactive sexual desire disorder (HSDD) and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p less than 0.001).

Study Shows LibiGel Significantly Increases Sexual Activity in Menopausal Women

2008-01-02T09:53:00.000-08:00

Study results showed an effective dose of LibiGel that significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); href="http://findarticles.com/p/articles/mi_m0EIN/is_2004_Sept_22/ai_n6208080">

U Va. Tests Libi-gel, female viagra

2008-01-02T09:49:00.000-08:00

CHARLOTTESVILLE, Va. (AP) - A drug that could do for women what Viagra has done for men is being tested at the University of Virginia.

The drug is a testosterone-laden ointment called LibiGel and it's intended to boost the libido of women who have lost interest in sex.

It will be prescribed at UVa in coming months to women who are suffering from hypoactive sexual desire disorder.

The condition is believed to affect one-third of American women.

"It is the most common sexual problem that women have," said Dr. Anita Clayton, a psychiatrist with the UVa Health System and author of the 2007 book "Satisfaction: Women, Sex and the Quest for Intimacy."

UVa joins 99 other medical institutions participating in testing the drug's efficacy and safety.

If given the green light by the U.S. Food and Drug Administration, Illinois-based BioSante Pharmaceuticals Inc. hopes to offer the drug to any woman complaining of a low sex drive.

For now, though, Clayton will enroll 25 women between the ages of 30 and 65 to take part in the national study.

Those women must have had both ovaries surgically removed, be currently taking an estrogen supplement and be distressed about their lack of libido.

Ovariectomies, or surgical menopause, can lead to a drop in sexual interest because ovaries produce roughly half of the testosterone in a woman's body.

Testosterone plays a key role in sexual functioning for men and women.

LibiGel comes in a pump bottle. The woman rubs the small dot of gel into the skin of her upper arm. Over the next 24 hours, the gel's testosterone seeps into her bloodstream, boosting her energy and libido.

Clayton, who is running the clinical trial at UVa, said the drug is better than previous testosterone treatments because it keeps levels of the chemical constant, much like naturally occurring testosterone.

"I expect this will work," she said.

In its second-phase clinical trials at 17 institutions, LibiGel led to a 283 percent increase of satisfying sexual encounters for the women taking the drug.

"A lot of women have this problem, but unfortunately they've been largely ignored by pharmaceutical companies," said BioSante's chief executive, Stephen M. Simes. "It's not fair that women have no drugs, while men have many."

http://www.wtop.com/?nid=600&sid=1318266

New Drug to Treat Female Sexual Dyfunction and Increase Libido

2008-01-02T09:45:00.000-08:00

BioSante Pharmaceuticals, Inc., a drug development company that uses nanotechnology to develop their products, have announced that it has successfully completed validation studies required as part of the clinical development program of LibiGel for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD). The data will be presented today at the annual meeting of the North American Menopause Society in Dallas, Texas.

As per U.S. Food and Drug Administration (FDA) published guidance for Patient Reported Outcome (PRO) studies, the pivotal efficacy studies of LibiGel require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. BioSante has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire. BioSante worked with FDA’s Division of Reproductive and Urologic Products and followed the FDA’s guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of Sexual Events and Desire (ISED) was able to differentiate between women with HSDD and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p < 0.001).

http://www.azonano.com/news.asp?newsID=5067

bioSante Pharmaceuticals : LibiGel and Elestrin patents announced

2008-01-02T09:42:00.000-08:00

http://www.techconnect.org/news/show.html?id=1785About Elestrin™

Elestrin is a fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator thereby allowing for precise, uniform dosing. The gel dries quickly in one to two minutes.

About LibiGel®

LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.

BioSante Pharmaceuticals : LibiGel® (transdermal testosterone gel) in the Treatment of Female Sexual Dysfunction

2008-01-02T09:39:00.000-08:00

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bio-identical estradiol and testosterone. BioSante's lead products include Elestrin™ (estradiol gel), developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel® (transdermal testosterone gel) in Phase III development for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration. Additional information is available online at www.biosantepharma.com.

http://www.techconnect.org/news/show.html?id=1677

LibiGel® Is Key to Unlocking the Value of BioSante

2008-01-02T09:33:00.000-08:00

BioSante Pharma (BPA) is a biopharmaceutical company that licenses and develops hormone therapy products to treat men and women. Hormone therapy gel products include Elestrin™, LibiGel®, Bio-E/P-Gel, LibiGel®-E/T, Bio-T-Gel and Triple Hormone Contraceptive (such as The Pill-Plus). The Company’s hormone therapy products are gel formulations of testosterone, estradiol, and combinations of estrogens, progestogens and androgens. Symptoms addressed by hormone therapies include menopausal symptoms in women, including hot flashes, vaginal atrophy, decreased sexual desire, sexual activity and impotence, lack of sex drive and muscle weakness in men. The primary goal of hormone therapy is to safely and effectively relieve these symptoms with minimal side effects. The Company is also engaged in the development of its calcium phosphate nanotechnology (CaP), primarily for vaccine adjuvants or immune system boosters and drug delivery systems. CaP products in development are BioVant, BioOral, BioAir and BioCap. The Company submitted a New Drug Application (NDA) for Elestrin™, in February 2006, and received approval in December 2006.

article link: http://www.zangani.com/node/962

BioSante Pharmaceuticals Initiates Phase III Study of LibiGel® (transdermal testosterone gel) in the Treatment of Female Sexual Dysfunction

2008-01-02T09:30:00.000-08:00

“Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD)," said Stephen M. Simes, president and chief executive officer of BioSante.

“We are encouraged by the clinically significant improvement in sexual events with LibiGel treatment in the Phase II study,” said Michael C. Snabes, MD, PhD, a reproductive endocrinologist and Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology and BioSante’s key clinical development consultant. “Since there are no medications approved by the FDA for the treatment of this common disorder, there is significant demand by patients and their physicians. We are hopeful that if and when LibiGel is approved by the FDA that LibiGel treatment will be able to improve the sex lives of women with low sexual desire and activity.”

Libi-gel female viagra Phase III trials announced

2008-01-02T09:27:00.000-08:00

As previously announced by BioSante, treatment with LibiGel® in a Phase II study, significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II study results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p less than 0.0001); this increase also was significant versus placebo (p less than 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II study was a double-blind, placebo-controlled study, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

"Based on discussions with the FDA and our positive results from the LibiGel Phase II study, we are moving forward into Phase III pivotal studies of women with low sexual desire, the largest component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD)," said Stephen M. Simes, president and chief executive officer of BioSante.

article link: http://www.biospace.com/news_story.aspx?NewsEntityId=41225

Phase II trial for Libigel, female viagra, completed

2008-01-02T09:22:00.000-08:00

he trial was a double-blind, placebo-controlled study, conducted in the United States, that included 46 patients to determine the effect of LibiGel on women's sexual desire and activity. The primary data (frequency of satisfying sexual events) from the phase II trial currently are being analyzed.

The safety profile for subjects receiving LibiGel was similar to that observed for subjects in the placebo group. There were no serious adverse events and no discontinuations due to adverse events in any subject receiving LibiGel, indicating the safety and acceptability of LibiGel.

"We concluded the LibiGel phase II trial earlier than anticipated based on a previous interim analysis, and on data recently announced by Procter & Gamble on a phase III clinical trial of their testosterone patch for FSD," said Leah M. Lehman, vice president of clinical and regulatory affairs for BioSante.

"The P&G study data indicate that the testosterone patch resulted in a statistically significant increase in sexual activity in women. Based on the interim analysis we are confident that LibiGel will have similar effects and expect the final data from our phase II clinical trial will allow us to move into phase III," Lehman said.

BioSante announced late last year that a blinded interim analysis of the then ongoing phase II trial of LibiGel showed statistically significant results for the primary endpoint of the study.

The interim study data, presented at a meeting of the International Society for the Study of Women's Sexual Health (ISSWSH) in Amsterdam, showed that after 3 months of treatment there was a 130% increase in the frequency of satisfying sexual events as measured by individual patient diaries.

article link: http://www.obgyn.net/newsheadlines/womens_health-Female_Sexual_Dysfunction-20040719-57.asp

Gel significantly increases sexual activity in surgically menopausal women

2008-01-02T09:19:00.000-08:00

LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group, with no serious adverse events observed. Notably, there was minimal application site irritation reported; in contrast, during previous trials with a transdermal testosterone patch delivery system, approximately 30 percent of subjects reported such reactions. Approximately 43 percent of American women suffer from FSD, according to a study published in the Journal of the American Medical Association. Currently, there is no FDA-approved pharmaceutical treatment for this condition. "These impressive results support the potential of LibiGel in helping to safely and effectively improve sexual activity in menopausal women," said James A. Simon, M.D., Clinical Professor of Obstetrics and Gynecology, George Washington University, Washington, D.C.; Medical Director, Women's Health Research Center, Laurel, Maryland and lead investigator of the study. "These study data show the ability of LibiGel to increase women's sexual functioning and enjoyment, and provide a valuable alternative for testosterone delivery in the treatment of female sexual dysfunction."

article link: http://www.womenfitness.net/news/womens_health/au_sexual_activity.htm

Libi-gel goes into trials- female viagra

2008-01-02T09:16:00.000-08:00

Dr. Shames stated that the FDA acknowledges testosterone's efficacy in treating HSDD and the need for testosterone products to be approved for women affected by this condition. As extended long-term, pre-marketing safety studies are often not economically feasible for companies, the FDA will now permit a complete safety profile to be submitted post-marketing, with efficacy and some safety data submitted pre-approval. The agency will assist companies in determining the best development plan for their testosterone products, consistent with the need for sufficient efficacy and safety requirements. The FDA is most interested in safety data addressing cardiovascular and breast cancer risk associated with testosterone therapy.

link: http://salesandmarketingnetwork.com/news_release.php?ID=2008206

Intrensa, Libi-gel- treatment for female sexual disfunction

2008-01-02T09:13:00.000-08:00

About LibiGel and Female Sexual Dysfunction (FSD)
LibiGel is a once-daily transdermal testosterone gel in late-stage clinical development for the treatment of FSD in surgically menopausal women who have had both ovaries removed. LibiGel's formulation of bioidentical testosterone is quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time in a non-invasive, painless manner.
Approximately 43 percent of American women suffer from FSD, according to a study published in the Journal of the American Medical Association. FSD is often defined as a lack of sexual desire, arousal or pleasure. The majority of women with FSD are postmenopausal, experiencing symptoms due to hormonal changes that occur with aging, or with natural or surgical menopause.

BioSante Pharmaceuticals Initiates Phase III Study of LibiGel® (transdermal testosterone gel) in the Treatment of Female Sexual Dysfunction

2008-01-02T09:11:00.000-08:00

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today that it has initiated a Phase III safety and efficacy trial of LibiGel® (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD). The double-blind, placebo-controlled Phase III trial will enroll approximately 360 surgically menopausal women for a six-month clinical trial, conducted under a Phase III protocol and investigational new drug application (IND) reviewed by and on file with the U.S. Food and Drug Administration (FDA).

As previously announced by BioSante, treatment with LibiGel® in a Phase II study, significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II study results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II study was a double-blind, placebo-controlled study, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

link: http://www.nsti.org/press/PRshow.html?id=1572

Avenavin for Female Impotence

2008-01-02T09:09:00.000-08:00

Do you commonly avoid sexual intimacy? Is your partner complaining because you lack the sexual energy or desire you used to have? You are not alone. Statistically, more women suffer from poor sex drive then men. Approximately 48% of women surveyed complained that they lack sexual motivation, while only 39% of the men questioned had ever experienced poor sex drive or troubled arousal. The frequency and duration of sexual deterioration leaned heavily on the side of women. Many women are depressed, anxious and uneasy about their situation and if untreated, the consequences can run deep. There is no reason for intimacy to feel like a chore and Avenavin is helping women all over the globe experience the desire, sexual energy and pleasure that's been missing for so long.

Female impotence is a serious problem and Avenavin helps women of all ages quickly restore sexual motivation and desire leading up to intimacy while heightening responsiveness, pleasure and orgasm during sexual activity. Making the most of your sex life is easy, natural and extremely inviting with Avenavin.

http://www.avenavin.com/

Getting Close to a Female Viagra?

2008-01-02T09:07:00.000-08:00

Link: http://www.foxnews.com/story/0,2933,262784,00.html

In late 2004, FDA approval of Intrinsa, a testosterone patch for low female sex drive, seemed imminent. News reports heralded Intrinsa as a "Viagra for her," suggesting that it would revolutionize sexual health for women just as erectile dysfunction pills had for men.

Except an FDA advisory panel saw things differently. Finding numerous problems with the evidence for the drug's effectiveness and safety, experts on the panel voted against approving it. Procter & Gamble, the company responsible for Intrinsa, withdrew its application. Procter & Gamble is a WebMD sponsor.

Now the frontrunner in the race to market the first prescription drug for low female sex drive is Boehringher-Ingelheim Pharmaceuticals. It has a drug called flibanserin in phase III clinical trials, the final phase of drug testing required for FDA approval. The company is a WebMD sponsor.

2008-01-02T09:06:00.001-08:00

Link: http://www.msnbc.msn.com/id/12867311/

FORT LEE, N.J. - A New Jersey drug company says an inhaler it’s working on could be the long-sought female version of Viagra.

Palatin Technologies of Fort Lee says it’s had encouraging results in both men and women with Bremolanotide, which stimulates the brain, rather than the genitals.

The company’s director of preclinical development says it may help women who lack desire and have trouble getting aroused.

female viagra?

2008-01-02T09:04:00.000-08:00

From: http://health.discovery.com/centers/womens/viagra/viagra_02.html

"Cure in a Pill?
Even so, drug companies — banking on the success of Viagra — hope to find its female equivalent. At the moment, they are focused on developing a drug that increases blood flow to the female genitals, resulting in vaginal lubrication and relaxing vaginal muscles.
The concept is similar to Viagra, which increases blood flow to the penis, resulting in an erection. So far, there are some promising drugs on the horizon. These include prostaglandin, already approved for men, apomorphine and phentolamine, both of which are being tested for arousal disorder in women.

Whether drug companies succeed, the good news is that women needn't wait for a sex pill. They have options. Research shows that exercise, counseling, vaginal lubrication products and sex videos all can help put spur a woman's libido.

What's more, the three following options — while scientifically unproven — are readily available and also hold the promise for improving a woman's sex life.

L-arginine amino acid cream
The same amino acid that has been used by athletes to promote muscle development is purported to increase blood flow to the female genitals, thus sparking sexual urges. "Our informal studies on 500 patients showed that 70 percent of women who applied this cream to the clitoris and labia a half hour before sex reported more arousal and stronger orgasms," says Dr. Jed Kaminetsky, clinical assistant professor of urology at the New York School of Medicine.
DHEA
Dehydroepiandrosterone is a male hormone produced by the adrenal gland and ovaries and converted to testosterone and estrogen. DHEA, which depletes with age, can be purchased over the counter in supplement form.In one small study published in the New England Journal of Medicine (Sept. 30, 1999), women who took 50 mg of DHEA daily noticed a significant increase in sexual interest. Other preliminary findings report encouraging results. However, most DHEA products lining the store shelves recommend taking only 25 mg per day. Because of its potential for heart attacks and breast cancer and masculating side-effects such as facial hair, DHEA is best used under a doctor's supervision.
Testosterone therapy
For women who have undergone oophorectomy (the removal of one or both ovaries) and hysterectomy, testosterone treatment has shown to improve sexual function and psychological well being, according to recent research from Boston's Massachusetts General Hospital.
However, women looking to boost testosterone levels should work with their physician closely so the hormone can be monitored. Too much of it can cause, among other things, facial hair and change a women's voice, which is irreversible. Meanwhile, a study looking at the combination of L-arginine glutamate and yohimbine — a natural extract from tree bark that excites part of the central nervous system — has shown that postmenopausal women were more than twice as aroused after taking the combination drug and viewing an erotic film than women who took a placebo."

Melatanon - Female Viagra?

2008-01-02T09:00:00.000-08:00

A product called Melatanon is being hailed as a possible female version of the sexual enhancement drug for men, Viagra. It causes a slight darkening of the skin and increased sexual interest. Sex drive seems to be enhanced by unknown means.

New Female Viagra being tested

2008-01-02T08:53:00.000-08:00

Products hailed as a new "female viagra" promise more active and fullfilling sex lives for women.
http://www.kriyayoga.com/love_blog/modules/mod_rss/rss.php/2.0 - 3.0 posts per week