FDA approves a new drug for increasing libido in premenopausal women

Courtesy: AMAG Pharmaceuticals

The US Food and Drug Administration (FDA) recently approved bremelanotide (Vyleesi, AMAG Pharmaceuticals), for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Vyleesi, a melanocortin receptor agonist that comes as autoinjector, joins flibanserin(Addyi, Sprout Pharmaceuticals) as the class of drugs approved by the FDA for the treatment of acquired HSDD. Flibanserin is Serotonin 5-HT-Receptor Agonists and is taken orally.

HSDD is the most commonly prevalent female sexual dysfunction and is largely under-recognized and undertreated. It is believed that approximately 9% of all premenopausal women in the United States experience it but less than half of these patients seek help or initiate discussions with physicians.

 “Women with HSDD often avoid situations that could lead to intimacy, the impact of which goes far beyond the bedroom and can often result in anxiety, loss of vitality, self-esteem issues and relationship stress. It is important that women suffering from this condition have a choice of treatment options available to them,” quote Anita H. Clayton, M.D., Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, VA in an AMAG Pharma news release.

The upside of bremelanotide is women need to use it as required as opposed to flibanserin which must be consumed daily.  The drug is dispensed as prefilled autoinjector pen which has to be self-administered by the woman into her abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day.

Courtesy: AMAG Pharmaceuticals

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.

While the exact mechanism of action is still unknown, the drug is believed to act on the melanocortin receptors in the central nervous system that are thought to be associated with sexual function.

The FDA approval of Vyleesi is based upon data from approximately 1,247 women in two pivotal (NCT02333071 and NCT02338960), replicate, double-blind placebo-controlled Phase 3 trials (RECONNECT). Most patients used the drug 2-3 times a month with no more than once a week.

Vyleesi does not enhance sexual performance, but there was a statistically significant increase in desire and decrease in distress at the time of intimacy. Women in both the trials didn’t experience any problem with the autoinjector.

The most common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. An increase in blood pressure was also noted, which usually resolved in 12 hours. Hence, Vyleesi is contraindicated in patients at high risk of cardiovascular disease and those with high-blood pressure.

Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men. AMAG is expected to make Vyleesi commercially available in September 2019 through select specialty pharmacies.

FDA press release

AMAG Pharmanews release