FDA Gives Female Sex Drive Drug a Second Chance

A drug that helps women maintain a healthy sex drive has been given another shot at approval by the Food and Drug Administration (FDA), Sprout Pharmaceuticals proclaimed Tuesday morning.

The drug, flibanserin, is a non-hormonal daily treatment that helps raise sex drive in women who suffer from hyperactive sexual desire disorder (HSDD). The disorder, which commonly gives women suffering from it a very low libido, often results in unhealthy levels of stress in women and may even result in depression.

In clinical trials, taking one flibanserin pill a day almost doubled the increase women saw in satisfying sexual experiences over a month's time, compared with patients who took a placebo, according to a Sprout release.

According to a Sprout Pharmaceuticals press release, the FDA originally denied the drug's approval due to a "moderate" side-effect of sleepiness, that might pose a risk to users when driving. Sprout appealed for a second look, which it was granted after the submission of  14 new clinical studies with data on more than 3,000 new patients, expanding the number of subjects having completed clinical trials to more than 11,000. The FDA says it will consider flibanserin for prescribed medical use in the U.S. once more after Sprout launches two more 50 patient studies to re-evaluate its safety.

Nothing has been said as to whether the drug can be used to raise sex drive in post-menopausal women as well, but the possibility should not be forgotten. After menopause, women often experience a markedly significant drop in sex drive due to a decrease in hormones, according to womenshealth.gov. Recent research into sexual activity of middle-aged women has shown that while this is usually the case, post-menopausal women still have a desire for sex unrelated to physical desire. Whether the non-hormonal fibanserin can be used to help older women with their fading desires remains to be seen, as the drug has yet to even be approved for its intended clinical use.

After finishing the new required trials, Sprout expects to resubmit the New Drug Application for flibanserin by the third quarter.

Sprout Pharmaceuticals released information on the FDA appeal in a Feb. 11 press release.