New Treatment for HSDD Granted FDA Approval for Premenopausal Women
The effectiveness and safety of bremelanotide were studied in a pair of 24-week, randomized, double-blind, placebo-controlled trials in 1247 premenopausal women with acquired, generalized HSDD.
Officials with the have approved bremelanotide (Vyleesi, AMAG Pharmaceuticals) 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, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition,” said Hylton V. Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, in a prepared statement. “As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.”
In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. In 2016, the FDA published a draft guidance to assist companies developing drugs for the treatment of these conditions.
Bremelanotide activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown. Patients inject the drug under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity and may decide the optimal time to use bremelanotide based on how they experience the duration of benefit and any adverse effects, such as nausea.
Patients should not use more than 1 dose within 24 hours or more than 8 doses per month. Patients should discontinue treatment after 8 weeks if they do not report an improvement in sexual desire and associated distress.
The effectiveness and safety of bremelanotide were studied in a pair of 24-week, randomized, double-blind, placebo-controlled trials in 1247 premenopausal women with acquired, generalized HSDD. Most patients used bremelanotide 2 or 3 times per month and no more than once a week. In these trials, about 25% of patients treated with this drug 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 to about 17% of those who took placebo. Additionally, about 35% of the patients treated with bremelanotide had a decrease of 1 or more in their distress score (scored on a range of zero to four, with higher scores indicating greater distress from low sexual desire) compared to about 31% of those who took placebo. There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events. Bremelanotide does not enhance sexual performance.
The most common adverse effects of bremelanotide 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 bremelanotide injection, and 13% needed medications for the treatment of nausea. About 1% of patients treated with this drug 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 adverse effect.
In the clinical trials, bremelanotide increased blood pressure after dosing, which usually resolved within 12 hours. Because of this effect, bremelanotide should not be used in patients with high blood pressure that is uncontrolled or in those with known cardiovascular disease. This drug is also not recommended in patients at high risk for cardiovascular disease.
FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women [news release]. Silver Spring, MD; June 21, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women. Accessed June 2019.