FDA Advisory Committees recommend ADDYI (flibanserin) for treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women- Sprout Pharma

The FDA joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee determined by an 18 to 6 vote that the benefit/risk profile of Sprout Pharmaceuticals� ADDYI (flibanserin) supports FDA approval for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, but only if certain risk management options beyond labeling are implemented.

ADDYI has been studied in more than 11,000 women, making it one of the most studied women�s health products in history. In three 24-week randomized Phase III, six-month, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years, ADDYI consistently demonstrated a highly statistically significant difference over placebo on three key endpoints, including increase in sexual desire, decrease in distress from the loss of sexual desire and increase in the frequency of satisfying sex. Women treated with ADDYI showed significant improvements at every point of measurement in all pivotal clinical trials, with benefits seen as early as four weeks and sustained over the 24-week treatment period. In addition to achieving statistical significance on all treatment success standards, the women in the clinical trials themselves judged their improvements to be meaningful to them. The women in the ADDYI clinical trials were in long term relationships for 10 years, they had HSDD for half of that time on average (4-5 years) and within 6 months ADDYI improved 43%-60% of them.