The FDA recently approved an appeal for the drug, Flibanserin, which is designed to treat low libido in women. Originally the FDA rejected the drug on the grounds that it only had a "modest" effect in correcting low sex drive in women. In light of new clinical trials, the FDA agreed to reexamine the drug.
[jump]Viagra, the first FDA approved drug for erectile dysfunction, ED, hit the shelves 15 years ago. Since then, ED drugs have become big business, commanding a $4.4 billion market in 2012. Many companies have tried to duplicate this success by creating similar drugs for women. An estimated 2 in 5 women experience some form of sexual dysfunction, and 1 in 10 women report having a low sex drive that results in personal distress. The problem these companies discovered is that low libido is a psychological issue as opposed to a physical one like most forms of ED.
Pfizer, who pioneered Viagra, ended its search for a female equivalent in 2004. The privately owned Sprout Pharmaceuticals Inc. acquired the rights for Flibanserin from another company in 2011 after the FDA ruled that the drug hadn’t been proven safe or effective.
Sprout recently gave the FDA data on 11,000 women who participated in clinical trials on Flibanserin. These women counted the number of satisfying sexual encounters they experienced each month. The average number of satisfying sexual events women recorded increased by 2.5 encounters in a 28-day period compared with 1.5 for those who received a placebo.
Flibanserin is a non-hormonal drug that works similar to antidepressants. It lowers serotonin while boosting dopamine and norepinephrine. It is only meant for pre-menopausal women, and common side effects include fatigue, nausea and sleepiness.
The FDA is expected to rule on the drug in the first few months of 2014.