FDA Seeks More Information on Female Libodo Drug

FDA Seeks More Information on Female Libodo Drug

February 11th, 2014 // 7:08 pm @

Sprout Pharmaceuticals, a pharma company that has been working on a drug to increase libido in women, has been asked to provide more clinical studies to FDA.

FDA wants to see more information on how the drug – flibanserin – interacts with other drugs and how it affects one’s ability to drive. About 10% of women in the firm’s clinical trials have reported that the drug makes them sleepy.

FDA’s query is another roadblock for pharma’s search for a drug that is equivalent to Viagra, but for women.

However, the CEO of Sprout Pharmaceuticals said this week that this demand for more data from FDA is a big step towards flibanserin’s approval. The studies that have been requested by the agency are small, with about 50 patients in each. The company has stated that it will resubmit the drug application in the third quarter of 2014.

Sprout is based in Releigh, NC, and FDA and the company had reached an impasse a few months ago when FDA issued another rejection of the drug. Sprout protested the decision, and FDA then asked for more clinical trial data.

If it is ever approved, Sprout’s drug would be the first pill for women who report a lack of sex drive. This is a market that pharma has been trying to win since Viagra took off in 1998. Earlier types of drugs focused on levels of hormones, but flibanserin is the very first drug that tries to boost libido by working on chemicals in the brain that affect our mood and appetite.

The race to come up with a way to boost female libido was once mainly the territory of big pharma, but now this space is mainly occupied by small start up companies. That company bought flibanserin from Boehringer Ingelheim three years ago. That company had given up on developing the drug after FDA had rejected it as well. Studies by Boehringer showed that women who took the drug only had a minor increase in sexual desire.


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