About 1,000 women will use BioSante Pharmaceuticals Inc.'s testosterone gel and keep sex diaries in a study approved by U.S. regulators to determine whether the treatment boosts women's sex drive and satisfaction.
The special protocol designed by BioSante, the maker of hormone treatments, and the Food and Drug Administration will show whether the gel aids statistically significant sexual satisfaction, the Lincolnshire, Ill.-based company said in a statement. BioSante says the study of post-menopausal women may lead to the first U.S.-approved medical treatment for female sexual dysfunction.
If the gel, called LibiGel, wins FDA approval it could be alone in the U.S. market, which chief executive officer Stephen Simes said may be bigger than the $2 billion a year in U.S. sales for male erectile drugs.
Pfizer Inc. failed to prove Viagra could boost women's sex drive, and Procter & Gamble Co.'s testosterone patch Intrinsa won approval only in Europe.
"Men have many, many choices including Levitra, Viagra and Cialis, as well as a testosterone market," Simes said in a phone interview Tuesday. "Today women have no choices" if they lose their sex drive, he said.
More women report sexual problems than men, Simes said. A treatment that increases frequency and satisfaction of intercourse, oral sex or masturbation for women could be bigger than Pfizer's Viagra for men, he said.
BioSante's LibiGel, based on the male hormone testosterone, is applied to the upper arm once daily and is absorbed through the skin.
Women naturally produce testosterone, though the amount drops by about half as women age from their 20s to 50s, said Simes.
After a woman goes through menopause or has her ovaries removed, estrogen production slows, leading to symptoms that can include hot flashes and vaginal atrophy.
Estrogen replacement treats some symptoms, but "doesn't do anything for arousal or desire disorders," Simes said.
In February 2004, Pfizer, the world's biggest drugmaker, halted Viagra testing on female sexual arousal disorder because of "inconclusive" results, the company said in an e-mailed response to questions.
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