FDA Says Female Sexual Dysfunction Pill May Not Be So Hot

Sprout Pharmaceutical has not lost desire for its female sex pill. Despite receiving a complete response letter from the FDA, the little drugmaker is appealing the agency decision. Nonetheless, the agency decision is only the latest instance in which the pharmaceutical industry has come up empty trying to market a drug to treat Hypoactive Sexual Desire Disorder in pre-menopausal women. In fact, the Sprout once-a-day pill, which is called flibanserin,  is the same drug that Boehringer Ingelheim failed to get approved three years ago. An FDA panel voted 10-to-1 the drug was not effective in increasing female libido, and then voted unanimously that potential side effects, such as depression and a loss of consciousness, were unacceptable. The pill, which Sprout purchased two years ago, is designed to increase libido in women by acting on brain chemicals linked to mood and appetite. In a statement disclosing its haggling with the FDA, Sprout would only say that the agency characterized flibanserin as having a modest effect in its risk-versus-benefit evaluation. And the drugmaker appeared frustrated at the agency move, despite having submitted 14 new clinical studies with data on more than 3,000 new patients, which expanded the number of subjects that completed clinical trials to more than 11,000, including more than 5,000 who were treated with flibanserin in Phase III efficacy studies. However, women taking the pill reported only 1.7 more satisfying sexual experiences per month t...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs