A Food and Drug Administration panel voted 18-6 on Thursday to recommend FDA approval of Sprout Pharmaceuticals’ women’s libido drug flibanserin, which many refer to as a “Viagra for women,” The Associated Press reported. However, the panel attached a contingency that requires the drugmaker to develop a plan for limiting the risks associated with taking the daily pill.
Thursday’s development is a recommendation and is non-binding. Historically, the FDA often follows the recommendations of its advisory panel, but it has deviated in the past. Flibanserin has been rejected by the FDA twice before, most recently in 2013 over concerns that the drug’s benefits don’t outweigh its risks.
Flibanserin is a small pink pill that is meant to be taken once daily at bedtime, according to The New York Times. It would treat the lack of sexual desire in premenopausal women, which can’t be attributed to disease or other known factors. Sprout Pharmaceuticals has said that 7 percent of premenopausal women experience the condition, known as hypoactive sexual desire disorder.
Panelists noted several safety issues, including low blood pressure and fainting spells associated with the drug, according to The Associated Press. Tests showed an increase in those problems when patients using flibanserin combined it with alcohol and other commonly-used medications, like anti-fungal drugs.
Flibanserin was originally developed as a depression treatment by Boehringer and Ingelheim, a German pharmaceutical company. But it was repurposed as a libido treatment and then sold in 2011 to Sprout Pharmaceuticals, a North Carolina-based startup.
Watch the above video explainer that will bring you up to speed on what you need to know about flibanserin, including how to pronounce flibanserin. The proposed trade name of the drug, should it win FDA approval, might be something that’s easier to pronounce: Girosa. A decision is expected from the FDA sometime in August.