Sprout Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) 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 U.S.

“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, chief executive officer, Sprout. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

Flibanserin has been studied in more than 11,000 women. The FDA approval of Addyi is largely based on three North American, Phase 3, 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.