The Food and Drug Administration says it needs more evidence before it approves a new drug that promises to boost female sex drive.
The agency told Sprout Pharmaceuticals that it needs to complete three additional human studies on their drug flibanserin, an experimental daily pill used to treat female sexual dysfunction, most specifically Hypoactive Sexual Desire Disorder (HSDD). The disorder causes women to experience a lack of sexual desire. If the drug receives approval, it will be the first on the market to treat women's libidos.
The agency wants more information on how the drug interacts with other medications, whether it impairs driving, and whether it causes sleepiness. About 10 percent of women taking the drug have reported extra sleepiness. Once the company submits the evidence, the FDA can consider it for approval.
Since erectile dysfunction drug Viagra became a hit over a decade ago, the pharmaceutical industry has been searching for a similar drug that would stimulate dormant sexual appetites in women. Flibanserin is thought to interact with neurotransmitters in the brain that influence sexual desire. The drug has been rejected in the past for lack of evidence, but Sprout Pharmaceuticals wants the FDA to give their drug another look.
Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals says they are pleased with the new FDA guidance. "In the absence of an approved solution, women with HSDD today are faced with the dilemma of trying unapproved products which could pose a safety risk or living with a condition that has important impact on their lives," says Whitehead.