Female libido pill took long, winding route to market

AP News
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Posted: Aug 19, 2015 12:05 AM

Federal health officials on Tuesday approved the first prescription drug intended to treat women suffering from a lack of sexual desire. The daily pill, which acts on brain chemicals, followed a long, winding path to approval, including two previous rejections by the Food and Drug Administration. Here's a look at the history:

— Pre-2009: German drugmaker Boehringer Ingelheim studies its drug, known chemically as flibanserin, as a treatment for depression in men and women. The drug had little effect, but researchers noticed patients reported increased sexual desire, suggesting an alternate use.

— 2009: Boehringer submits the drug to the Food and Drug Administration for approval to treat female hypoactive sexual desire disorder, a condition described as emotional distress caused by a lack of sexual desire. The FDA had never approved a drug for that condition or any other female sexual disorders.

— June 2010: A panel of FDA advisers votes unanimously against the drug, saying its benefits are outweighed by its risks, including side effects like dizziness, fatigue and fainting.

— Late 2011: Boehringer abandons the drug and sells it to Sprout Pharmaceuticals, a small North Carolina company.

— March 2013: Sprout resubmits the drug to FDA with additional data showing its benefits using a new measurement technique.

— September 2013: The FDA rejects the drug a second time, saying its benefits are "numerically small" and still don't outweigh "substantial safety concerns."

— December 2013: Sprout files a formal dispute against the FDA, arguing the agency should approve the drug without any additional data.

— February 2014: The FDA responds by proposing Sprout conduct additional studies, including one examining flibanserin's effects on driving, because of its drowsiness side effect.

— February 2015: Sprout resubmits the drug to the FDA with the requested studies. At the same time, the company helps fund a campaign called Even the Score, which lobbies the FDA to approve sexual medicines for women.

— June 2015: A panel of FDA advisers votes 18-6 in favor of approving the drug, with safety restrictions.

— August 2015: The FDA approves flibanserin, branded Addyi, as the first drug to treat any type of female sexual dysfunction. The drug includes a black box warning about side effects.