FDA Approval Sought for Female Sexual Disorder Drug

Share this article:

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.

Share this article:
You must be a registered member of RUN to post a comment.
close

Next Article in Reproductive Medicine

More in Reproductive Medicine

Stress Raises Infertility Risk in Women

Stress Raises Infertility Risk in Women

Higher levels of salivary alpha-amylase linked to longer time-to-pregnancy.

Mentally Ill Teens Face Higher Fertility Rates

Mentally Ill Teens Face Higher Fertility Rates

Fertility rate not declining as much over time in teen girls with major mental illness versus unaffected girls.

Children of Older Dads More Likely to Die Before Age 5

Children of Older Dads More Likely to Die ...

Excess risk of death found among children born to fathers aged 40 or older.