FDA panel recommends approval of Sprout Pharmaceuticals’ ADDYI™ for low female libido

WASHINGTON - June 5, 2015 - PRLog -- The U.S. Food and Drug Administration’s (FDA) meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee has decided to support the approval of the benefit/risk profile of Sprout Pharmaceuticals’ ADDYI™ (flibanserin) in an 18 to 6 vote to treat Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women .

“We are pleased with the positive outcome of today’s Advisory Committee meeting and the confidence that was expressed regarding the efficacy and safety of ADDYI,” said Cindy Whitehead, chief executive officer, Sprout Pharmaceuticals. “With today’s decision, we are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction. We look forward to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy (REMS).”

ADDYI has been assessed in over 11, 000 women and results from a Phase 3, six-month, double-blind, placebo-controlled, parallel-group study of premenopausal women with a mean age of 36 years revealed that ADDYI demonstrated statistical significance 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.

Female hypoactive sexual desire disorder (HSDD) tends to occur in up to one third of adult women in the United States. HSDD is a common form of sexual dysfunction in females and has been medically recognized for more than 30 years. HSDD is characterized by recurrent deficiency or absence of desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric (e.g., depression) or other sexual condition.

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