FDA approves Vyleesi for women with low sexual desire
Today, the FDA approved Vyleesi for the management of premenopausal women with hypoactive sexual desire disorder, according to a press release issued by the agency.
“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in the release. “Today’s approval provides women with another treatment option for this condition.”
The safety and effectiveness of Vyleesi (bremelanotide, Amag Pharmaceuticals Inc.) was confirmed in two 24-week, double-blind trials in which 1,247 premenopausal women with acquired, generalized hypoactive sexual desire disorder were randomized to receive bremelanotide or placebo, according to the release. Patients receiving bremelanotide injected the drug in the abdomen or thigh at least 45 minutes prior to sexual activity two to three times a month and not more than once a week, according to the release.
The studies showed that approximately a quarter of patients who received bremelanotide had an improvement in their sexual desire score by 1.2 or more points, compared with 17% of patients who received placebo, according to the release. Distress score decreased in 35% of patients taking bremelanotide vs. 31% of those taking placebo, according to the release. Bremelanotide did not increase sexual satisfaction, according to the release.
Nausea, vomiting, flushing, injection site reactions and headache were the most commonly reported adverse events, according to the release. BP rose after bremelanotide injection, but typically lowered to normal levels within 12 hours, according to the release.
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