FDA approves Addyi (flibanserin 100 mg) for hypoactive sexual desire disorder- Sprout Pharma

The FDA has granted approval of Addyi (flibanserin 100 mg), from Sprout Pharma, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Flibanserin is the first FDA-approved treatment for this condition.

The FDA approval of flibanserin 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, flibanserin 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 whom were exposed to treatment for at least one year. Flibanserin was administered to over 2,500 premenopausal women with acquired, generalized HSDD in clinical trials, over 850 receiving treatment for at least 12 months.

Flibanserin can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take flibanserin with moderate or strong CYP3A4 inhibitors that can interfere with the breakdown of flibanserin in the body. The use of alcohol is contraindicated while taking flibanserin.