FDA Needs More Information On Sprout's Female "Viagra" Drug

The FDA wants more information from Sprout Pharmaceuticals on their female “Viagra” drug, flibanserin. Sprout acquired the drug from Boehringer Ingelheim in 2011, and has since worked to develop it into a suitable option for women in western markets. Flibanserin is currently being used by adult women as an experimental drug to increase female sexual desire. The women currently taking flibanserin use it daily.

While Sprout maintains that flibanserin has promise and could potentially succeed, the FDA’s request for more information is seen in the industry as a setback for the company. Sprout revealed that up to 10% of all women taking flibanserin experienced “sleepiness,” and the FDA is interested in finding out how the drug will interact with other medications that patients might also be taking. Further, the FDA is interested in flibanserin’s impact on a patient’s ability to drive.

The FDA has asked Sprout for three small studies which could help regulators better understand the effectiveness of the drug. The studies would have up to 50 patients each. In December, the FDA rejected the second application for the approval of flibanserin. Sprout hopes to conclude the studies requested by the FDA in the next few months in time to resubmit their drug’s application for the third time this summer.

Source: http://www.usatoday.com/story/news/nation/2014/02/11/female-sex-pill-viagra/5390457/