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“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, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products, stated in a press release. “Today’s approval provides women with another treatment option for this condition.”
HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not caused by a medical or psychiatric condition. Acquired HSDD develops in a patient who previously experienced no problems with sexual desire, and generalized HSDD is a lack of desire that occurs regardless of the type of sexual activity, situation, or partner.
Vyleesi was studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. The women used Vyleesi two or three times per month and no more than once a week. About one-quarter of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire), compared with about 17% of those who took placebo. About 35% of the patients treated with Vyleesi had a decrease of one or more in their distress score (scored on a range of 0-4, with higher scores indicating greater distress from low sexual desire) compared with about 31% of those who took placebo.
The drug is injected under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. Patients may decide the optimal time to use Vyleesi based on the duration of benefit and any side effects, such as nausea. Patients should not take more than one dose of Vyleesi within 24 hours, or more than eight doses per month. Patients should discontinue treatment after 8 weeks if they do not report an improvement in sexual desire and associated distress.
Vyleesi works by activating melanocortin receptors but the exact mechanism for improving sexual desire is unknown. Some side effects were reported. “The most common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection, and 13% needed medications for the treatment of nausea. About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts, which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect,” according to the press release.
A temporary increase in blood pressure in patients after dosing with Vyleesi was observed during the clinical trials and therefore the drug is not recommended in patients at high risk for cardiovascular disease. In addition, patients who take a naltrexone-containing medication by mouth to treat alcohol or opioid dependence should not use Vyleesi because it may significantly decrease the levels of naltrexone in the blood and could lead to naltrexone treatment failure.
The full press release can be found on the FDA website.