The FDA has granted approval of Sprout Pharmaceuticals’ Addyi (flibanserin 100mg), 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 one in 10 women in the U.S.

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. Addyi 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. Discontinuation rates due to adverse events in the phase III 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.

Hypotension and syncope were seen rarely with Addyi alone but more frequently when Addyi was taken in the morning and when co-administered with alcohol or certain other drugs. Alcohol consumption is contraindicated for women taking Addyi. 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 also has committed to enhanced pharmacovigilance and phase IV studies to mitigate and further characterize the safety profile of Addyi.

Addyi is anticipated to be available by Oct. 17.