Maryland (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. |
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