MONDAY, June 24, 2019 — Vyleesi (bremelanotide) has been approved to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women, the U.S. Food and Drug Administration announced Friday.
Vyleesi is administered by patients as a 1.75-mg subcutaneous injection in the abdomen or thigh 45 minutes before anticipated sexual activity. Patients are advised to administer no more than one dose within 24 hours and no more than eight doses a month. If patients do not experience improvement in sexual desire and associated distress after eight weeks, they should discontinue treatment.
Approval of Vyleesi was based on data from two identical 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized hypoactive sexual desire disorder. Most patients reported using Vyleesi two to three times per month and no more than once per week. Researchers found an increase of at least 1.2 points in the sexual desire score for about 25 percent of patients treated with Vyleesi compared with about 17 percent of patients who received placebo. The distress score decreased by 1 point or more for 35 percent and 31 percent of patients who took Vyleesi and placebo, respectively.
The most commonly reported side effects were nausea and vomiting, flushing, injection site reactions, and headaches. In the clinical trials, about 40 percent of patients who received up to eight monthly doses experienced nausea; 13 percent of these patients required anti-emetic therapy, and 8 percent discontinued treatment prematurely. Focal hyperpigmentation was also reported in about 1 percent of patients. Vyleesi was found to increase blood pressure after dosing, so it should not be used in patients with uncontrolled high blood pressure or known cardiovascular disease. Vyleesi could also lead to naltrexone treatment failure, so patients taking oral medication containing naltrexone should not use Vyleesi.
Approval was granted to AMAG Pharmaceuticals.
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Posted: June 2019