FDA (Food and Drug Administration) approved Vyleesi (bremelanotide) indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
“There are women who, for no known reason, have reduced sexual desire that causes marked distress. This state can be improved with the help of safe and effective pharmacologic treatment. The approval of a new drug provides women with another treatment option for this condition,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.
Acquired HSDD develops in a patient who previously experienced no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.
Patients inject Vyleesi under the skin at least 45 minutes before anticipated sexual activity. They may decide the optimal time to use. Patients should not use more than one dose within 24 hours or more than eight doses per month. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.
The effectiveness and safety of Vyleesi were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 with hypoactive sexual desire disorder.