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news.The US FDA's advisory committee has recommended Sprout Pharmaceuticals' ADDYI (flibanserin) for women who are facing hypoactive sexual desire disorder (HSDD) during premenopausal period.
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The FDA’s joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee have voted 18 to 6 vote in support of the drug.
However, the agency requires Sprout to implement certain risk management options beyond labeling.
The FDA is not required to accept the panel’s recommendation, but it will consider its decision as part of the ADDYI new drug application (NDA) review. If approved, ADDYI will be the first FDA-approved treatment for HSDD.
Sprout Pharmaceuticals CEO Cindy Whitehead said: "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)."
HSDD is characterized by a deficiency in interest for sexual activity, resulting in distress or interpersonal difficulty.
Approximately one in three women in the US suffer from low sexual desire, and one in 10 women (16 million women total) are distressed by it, the company said.
ADDYI has been studied in more than 11,000 women, in three 24-week randomized Phase 3, six-month, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years.
The drug was tested to see if it increased sexual desire, decreased distress from the loss of sexual desire and increased the frequency of satisfying sex.
According to Sprout, ADDYI has consistently demonstrated a highly statistically significant difference over placebo on all the three key endpoints.
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 (four to five years) and within six months ADDYI improved 43%-60% of them, the company said.
The drug’s common side effects were dizziness, nausea and sleepiness.