Reuters
A pink pill that acts on brain chemicals has helped women with low sex drive, its German manufacturer said on Friday, arguing for the first U.S. approval of a drug to boost women's libido.
Officials of privately held drugmaker Boehringer Ingelheim aimed to convince an expert panel, over the doubts of government reviewers, that the pill offered meaningful benefits to women who want a medical option to increase their sexual desire.
The once-a-day pill called flibanserin is the latest attempt at a female counterpart to Pfizer Inc's Viagra, the blockbuster blue pill for men. In clinical studies, Viagra and other male impotence pills have failed to help women.
Boehringer is seeking Food and Drug Administration approval to sell the pill by prescription for premenopausal women with a persistent, bothersome and unexplained lack of sex drive.
"Women deserve the option to choose a safe and effective pharmacological therapy for this distressing condition," said Dr. Anita Clayton, a Boehringer consultant and psychiatry professor at the University of Virginia.
The company must overcome major concerns from FDA reviewers. In an analysis released on Wednesday, agency staff said the drug failed to boost sex drive in two studies as measured by women's diary entries.
Women did report slightly more satisfying sexual experiences -- an average of 4.5 per month compared with 2.8 before taking the medicine. For placebo patients, the rate jumped to 3.7 during the studies.
The drug's tolerability was "only moderate," FDA staff said. Nearly 15 percent of women who took the recommended flibanserin dose stopped doing so before the study ended due to possible side effects. Depression, fainting and fatigue were among the problems reported by women who took the drug.
Boehringer said most of the reported problems were mild.
The company also said an analysis based on women's answers to questions about their response showed a jump in sex drive and lower distress levels with the drug.
The advisory panel, a group of experts from outside the FDA, will vote later Friday on whether to recommend approval of flibanserin. The FDA, which will make the final decision, usually follows panel recommendations.
The drug's proposed brand name is Girosa. It is not yet approved anywhere in the world.
Flibanserin, which was originally tested as an antidepressant, acts on neurotransmitters in the brain. Viagra and other pills to treat male impotence work by widening blood vessels to increase the blood flow needed for an erection.
Drugmakers have tried various approaches to boost female libido, but women's sex lives have proved more difficult to target with medication.
Procter & Gamble Co tried to win U.S. clearance to sell a testosterone patch to treat female sexual dysfunction. An FDA advisory panel voted in 2004 against recommending approval, citing a lack of evidence for long-term safety. The patch was approved in Europe and has been sold to Warner Chilcott.
Another U.S. drugmaker, BioSante, is developing a testosterone skin gel to treat a decline in libido in menopausal women. The company estimates the market for treating female sexual dysfunction in the United States tops $2 billion annually.
Officials of privately held drugmaker Boehringer Ingelheim aimed to convince an expert panel, over the doubts of government reviewers, that the pill offered meaningful benefits to women who want a medical option to increase their sexual desire.
The once-a-day pill called flibanserin is the latest attempt at a female counterpart to Pfizer Inc's Viagra, the blockbuster blue pill for men. In clinical studies, Viagra and other male impotence pills have failed to help women.
Boehringer is seeking Food and Drug Administration approval to sell the pill by prescription for premenopausal women with a persistent, bothersome and unexplained lack of sex drive.
"Women deserve the option to choose a safe and effective pharmacological therapy for this distressing condition," said Dr. Anita Clayton, a Boehringer consultant and psychiatry professor at the University of Virginia.
The company must overcome major concerns from FDA reviewers. In an analysis released on Wednesday, agency staff said the drug failed to boost sex drive in two studies as measured by women's diary entries.
Women did report slightly more satisfying sexual experiences -- an average of 4.5 per month compared with 2.8 before taking the medicine. For placebo patients, the rate jumped to 3.7 during the studies.
The drug's tolerability was "only moderate," FDA staff said. Nearly 15 percent of women who took the recommended flibanserin dose stopped doing so before the study ended due to possible side effects. Depression, fainting and fatigue were among the problems reported by women who took the drug.
Boehringer said most of the reported problems were mild.
The company also said an analysis based on women's answers to questions about their response showed a jump in sex drive and lower distress levels with the drug.
The advisory panel, a group of experts from outside the FDA, will vote later Friday on whether to recommend approval of flibanserin. The FDA, which will make the final decision, usually follows panel recommendations.
The drug's proposed brand name is Girosa. It is not yet approved anywhere in the world.
Flibanserin, which was originally tested as an antidepressant, acts on neurotransmitters in the brain. Viagra and other pills to treat male impotence work by widening blood vessels to increase the blood flow needed for an erection.
Drugmakers have tried various approaches to boost female libido, but women's sex lives have proved more difficult to target with medication.
Procter & Gamble Co tried to win U.S. clearance to sell a testosterone patch to treat female sexual dysfunction. An FDA advisory panel voted in 2004 against recommending approval, citing a lack of evidence for long-term safety. The patch was approved in Europe and has been sold to Warner Chilcott.
Another U.S. drugmaker, BioSante, is developing a testosterone skin gel to treat a decline in libido in menopausal women. The company estimates the market for treating female sexual dysfunction in the United States tops $2 billion annually.
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