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Female Libido Pill Took Long, Winding Route To Market

Photo caption: Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-...

Photo credit: Associated Press

Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-drive drug Addyi at her Raleigh, N.C., office on Tuesday, Aug. 15, 2015.

Female Libido Pill Took Long, Winding Route To Market


Irwin Goldstein, president, Institute for Sexual Health

Barbara Gattuso, participant, Addyi clinical trial

David Peters, family therapist


Federal health officials on Tuesday approved the first prescription drug intended to treat premenopausal women suffering from a sudden 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.

Dr. Irwin Goldstein led clinical trials in San Diego on the drug known as Addyi. Goldstein will join David Peters a family therapist in San Diego to discuss the drug, reasons for its use, and what other relationship issues might contribute to loss of sexual desire. Barbara Gattuso, who was a participant in the clinical trial of Addyi will also join the discussion.

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.

KPBS' Maureen Cavanaugh, Patty Lane and Peggy Pico contributed to the Midday and Evening Edition segments.

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