Sprout Pharmaceuticals Receives FDA Approval for ADDYI 8/19/2015
The U.S. Food and Drug Administration (FDA) has approved Addyi (Flibanserin 100MG), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, and it is expected to be available by October 17, 2015.
Addyi (pronounced add-ee) 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 United States, according to Raleigh, N.C.-based Sprout Pharmaceuticals, Inc., which developed the drug.
“It has been a remarkable journey to get to this breakthrough moment," said Cindy Whitehead, CEO of Sprout. "Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition."
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.
Clinical Studies Behind Approval
Flibanserin has been studied in more than 11,000 women, and 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.
The safety of flibanserin is based on clinical trial data in more than 8,500 women, over 1,000 of which were exposed to treatment for at least one year. Addyi was administered to over 2,500 premenopausal women with acquired, generalized HSDD in clinical trials, over 850 receiving treatment for at least 12 months.4 Discontinuation rates due to adverse events in the Phase 3 trials were 13% for Addyi and 6% for placebo. The most common adverse events among patients treated with Addyi were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. With the FDA, Sprout Pharmaceuticals developed a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program, including prescriber and pharmacist certification, to ensure safe use of Addyi. Sprout has also committed to enhanced pharmacovigilance and Phase 4 studies to mitigate and further characterize the safety profile of Addyi.