FLIBANSERIN AND FEMALE SEXUAL DYSFUNCTION

IS THERE A CURE FOR FSD?

FLIBANSERIN FOR WEIGHT LOSS?

Female sexual dysfunction describes women who are indifferent or hostile to sexual intercourse, who have no response to sexual advances or stimulation, or who are unable to have an orgasm during sexual intercourse.

Female sexual dysfunction (FSD) affects an estimated 84 million women across the seven major pharmaceutical markets. Despite its high prevalence, FSD is poorly understood and defined.

Despite the relatively large patient population, currently there is just one approved drug treatment for FSD- P&G's Intrinsa (testosterone). Intrinsa (testosterone) is marketed in Germany, France and the UK.

The FDA rejection of Intrinsa for FSD has left a big gap in the market. There is much unmet need among patients and physicians consequently there is an opportunity to develop this market to parallel to that of the multi-billion dollar male erectile dysfunction market.

Depending on the outcome of ongoing clinical trials, there are several appealing inlicensing opportunities for larger companies wishing to unlock the potentially lucrative US market.

Flibanserin pills stimulate parts of the brain associated with emotions and pleasure, including a circuit that appears to control desire and sexual arousal.
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.

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

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.”

He added: “The aim of flibanserin is to return women’s sexual desire to a normal state — no excessive sexual effects have been reported from the treatment in any clinical trial.”

FLIBANSERIN CLINICAL TRIALS

24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Flibanserin Randomized Withdrawal Trial in Pre-Menopausal Women

To estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.

A safety and efficacy trial of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD)

The purpose of this study is to find out if the investigational drug, flibanserin, is safe and effective for the treatment of women with HSDD.

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