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."
Flibanserin Female
Libido Enhancer
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/s
how/NCT00360555
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