Vote came after agency twice rejected medication due to side effects
FRIDAY, June 5, 2015 (HealthDay News) — An advisory panel to the U.S. Food and Drug Administration recommended approval Thursday of flibanserin, a medication designed to treat hypoactive sexual desire disorder in premenopausal women.
The medication had been twice rejected by the FDA in recent years. Earlier trials of the drug revealed potential side effects such as fainting, nausea, dizziness, sleepiness, and low blood pressure, the Washington Post reported. The panel voted 18 to six that the FDA grant approval to flibanserin. However, the panel members who voted yes said full FDA approval should come with certain conditions. Those conditions include proper warning labels and education about side effects of the drug.
In earlier clinical trials conducted by Sprout Pharmaceuticals, which makes flibanserin, women whose average age was 36 took the medication for five months and reported an increased sexual desire, reduced distress, and an increase in “sexually satisfying events” compared with women taking a placebo, the Los Angeles Times reported. The latest application by Sprout included new information requested by the FDA about how the pill affects driving ability. FDA scientists asked for the data because previous results in company clinical trials found that sleepiness occurred in nearly 10 percent of women who took the drug. In the new study, Sprout compared the driving ability of women the morning after they took flibanserin with those who took a common sleeping pill or a placebo, the Associated Press reported.
Thursday’s endorsement by the advisory panel was somewhat muted, with the committee calling the drug’s benefits “moderate” or “marginal,” the Post reported. The FDA typically follows the recommendations of its advisory panels, but is not bound to do so. Formal approval of the drug could come by the end of summer, the newspaper said.
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