The FDA approved Addyi to treat hypoactive sexual desire in premenopausal women, making it the first FDA-approved drug to treat sexual desire disorders in either men or women.
The non-hormonal, once-daily drug Addyi (flibanserin, Sprout Pharmaceuticals), studied for efficacy in more than 11,000 women, gained recommendation for approval in June. Upon recommendation, the FDA Bone, Reproductive and Urologic Drugs Advisory Committee required that certain risk management options beyond labeling be implemented.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
Hypoactive sexual desire disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance, according to the FDA.
In a statement, Cindy Whitehead, chief executive officer of Sprout, called the approval a breakthrough moment.
“We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence,” Whitehead said in press release.
The safety of flibanserin has been evaluated in trial data from more than 8,500 women, with more than 1,000 of those women exposed to treatment for at least 1 year. The majority of side effects were mild, with dizziness, nausea and sleepiness reported most commonly.
The 100 mg bedtime dose of flibanserin was administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials. Within the cohort, about 1,700 received treatment for at least 6 months, and 850 received treatment for at least 1 year.
Flibanserin is being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with flibanserin, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. The FDA is requiring Sprout to conduct three well-designed studies in women to better understand the known serious risks of the interaction between flibanserin and alcohol, according to an FDA news release.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said in a statement. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
Flibanserin, is a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. The FDA recommended patients discontinue treatment after 8 weeks if they do not report an improvement in sexual desire and associated distress.