Sprout Pharmaceuticals Receives FDA Approval of Addyl (Flibanserin 100 MG)

Sprout Pharmaceuticals has received FDA approval for Addyi (flibanserin 100 mg), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the US.

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” said Cindy Whitehead, CEO of Sprout. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

HSDD is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.

Flibanserin has been studied in more than 11,000 women. The FDA approval of Addyi is largely based on three North American, Phase III, 24-week, randomized double blind, placebo-controlled, studies of premenopausal women with HSDD. For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.

Addyi is anticipated to be available by 17 October 2015.