(HealthDay News) — Addyi (flibanserin) has been approved by the U.S. Food and Drug Administration as the first drug to treat generalized hypoactive sexual desire disorder among premenopausal women. The drug is for women who do not have an underlying physical or psychological cause for the disorder, the agency said in a news release.
Addyi was evaluated in clinical studies involving some 2,400 premenopausal women. Users of Addyi reported a significant increase in sexual desire, compared to those who took a placebo. The most common adverse reactions included dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. Women who take the once-daily drug should discontinue use after 8 weeks if there’s no improvement in sexual desire, the FDA added.
Addyi’s label will warn that it can cause severe hypotension and may lead to loss of consciousness. These risks increase and symptoms may become worse when alcohol is consumed. Physicians who prescribe the drug and any pharmacy that dispenses it must be certified, the agency said. Pharmacies must warn users of the risks of drinking alcohol while on the medication.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
Addyi is marketed by Raleigh, N.C.-based Sprout Pharmaceuticals.