FDA Approval Sought for Female Sexual Disorder Drug
Flibanserin, a non-hormonal drug for the treatment of hypoactive sexual desire disorder (HSDD) in post-menopausal women, has been resubmitted for a New Drug Application, the drug's maker, Sprout Pharmaceuticals, of Raleigh, NC, announced.
Flibanserin demonstrated significant improvements in sexual events in a phase 3 randomized, placebo-controlled trial that included 1,100 premenopausal women with HSDD. The drug was well-tolerated in patients during the 24-week period.
“The consistency of flibanserin's statistically significant effect on satisfying sexual events and desire, while decreasing the distress of women experiencing HSDD, is very encouraging,” said Sheryl Kingsberg, PhD, of the Case Western Reserve University School of Medicine in Cleveland.
If it is approved, flibanserin will be the first biopharmaceutical option for women with sexual dysfunction.
In June 2010, the FDA voted against recommending and approving the drug—which was then being developed by Boehringer Ingelheim—for lack of compelling evidence.
Sprout expects FDA action before the end of 2013.