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In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble's testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.
BioSante Pharmaceuticals Inc. expects to submit its testosterone gel LibiGel for FDA approval next year.
Medical surveys have estimated more than 40 percent of women suffer from some form of sexual dysfunction; Boehringer estimates as many as one in 10 women could be helped by its drug.
Boehringer tried to zero in on the chemical aspect of sexual dysfunction by only testing its drug on premenopausal women who were in stable relationships and not taking other medications. Despite wanting to have a sexual relationship, the women enrolled in company studies reported a persistent lack of desire that caused them "distress or interpersonal difficulty."
Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one's relationship and lifestyle than brain chemicals.
During the public comment period at Friday's meeting, Tiefer will ask the FDA to reject flibanserin, arguing it offers meager benefits for women with unknown long-term risks.
The modest results reported by Boehringer have also cooled Wall Street's expectations for the drug.
Decision Resources analyst Alasdair Milton said he expects flibanserin sales to peak at $300 million after six or more years on the market. By comparison, male sexual dysfunction drugs including Viagra, Cialis and others posted combined sales of $4.4 billion last year, according to health care data firm IMS Health.
Privately-held Boehringer Ingelheim posted sales of $12 billion last year. The Ingelheim, Germany-based company makes a range of prescription drugs for heart disease, HIV and other diseases.
[Associated
Press;
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