Flibanserin Female Libido Enhancer

Flibanserin is a new drug in clinical trials that could do for women's sex drive what Viagra has done for men.

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Female Viagra Pill

German drugmaker Boehringer Ingelheim didn't set out to create a Viagra-like drug for women. The company was simply trying to develop a fast-acting antidepressant, one that patients would respond to in a matter of days, not weeks like most current treatments. By the late 1990s the company had developed a molecule called flibanserin that
seemed to relieve stress in rats.

Flibanserin an Antidepressant Bust

But like many promising drugs, it flopped in human trials. Says Dr. Lutz Hilbrich, the company's executive director of general medicine: "We did not see the effect we were expecting."

But what they did see surprised them. Like all companies working on antidepressants, Boehringer surveyed patients in its clinical trial to assess dampening of libido, a well-established side effect. Far from complaining about a drop in sexual desire and arousal, many of the women in the trial reported a surge. The men had no such response—and neither group showed any improvement in mood.

Flibanserin's Story Similar to Viagra's "It is an interesting drug," says Dr. André T. Guay, director of the Center for Sexual Function at the Lahey Clinic Northshore, Peabody, Mass., and assistant professor at Harvard Medical School. "These things come about in strange ways." It's hard to escape a comparison with Viagra. In the mid-1990s, researchers at Pfizer Inc.  were testing an experimental drug for angina, or chest pain, and were stunned to discover the stimulating side effect. Since Viagra hit the market in 1998, drugmakers have been searching for the female equivalent.

Procter & Gamble, for instance, is trying to win Food & Drug Administration approval for a testosterone patch that produces modest effects in women, and others are testing topical creams and nasal sprays. "It is a very large potential market for drug companies," says Cleveland Clinic urologist Dr. Jeffrey S. Palmer. Annual sales of erectile dysfunction drugs for men have already topped $2 billion. Boehringer has placed a big bet on flibanserin. The company has launched four major clinical trials, involving 5,000 women in 220 locations, with the goal of applying for FDA approval in 2009. http://www.businessweek.com/print/magazine/content/07_02/b4016050.htm?chan=gl

Clinical Trials
A 24-Week up-Titration Trial of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

This study is currently recruiting patients. Please refer to this study by ClinicalTrials.gov identifier  NCT00360555
clintriage@rdg.boehringer-ingelheim.com

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

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment Official Title: Best Tolerability: 50mg BID v 100 mg QHS v 25 mg BID v Placebo in Younger Women in NA/EU/UK

Primary Outcome Measures:
* The primary endpoints are the increases in how often women have satisfying sexual events and in how much their sexual desire increases. Both are measured by making daily entries in an electronic diary.

Secondary Outcome Measures:
* Changes from baseline on diary sexual distress question and on a small number of patient-completed questions/questionnaires.

Total Enrollment:  1400 Study start: July 2006;  Expected completion: June 2008.

http://clinicaltrials.gov/show/NCT00360555

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