The US Food and Drug Administration’s (FDA) reproductive and urologic drugs advisory committee has recommended Sprout Pharmaceuticals’ Addyi (flibanserin) for approval to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.
Supported by a vote of 18-6, the committee recommended the drug with certain conditions to minimise the risks.
Addyi is a multifunctional serotonin agonist antagonist (MSAA) and will be the first post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist to treat premenopausal women with HSDD, if approved.
Specifically, the drug is said to increase dopamine and norepinephrine (both responsible for sexual excitement), while transiently decreasing serotonin (responsible for sexual satiety/inhibition) in the brain’s prefrontal cortex.
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).”
Addyi was studied in around 11,000 women, including three 24-week randomised Phase III, six-month, double-blind, placebo-controlled and parallel-group North American studies of premenopausal women with a mean age of 36 years.
According to the firm, the drug consistently showed 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.
With benefits witnessed as early as four weeks and sustained over the 24-week treatment period, women treated with Addyi showed significant improvements at every point of measurement in all pivotal clinical trials, said the company.