Bremelanotide to treat low sexual desire in womenAugust 6, 2019
Amag Pharmaceuticals, Inc said the US FDA has approved bremelanotide injection (Vyleesi), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The prefilled bremelanotide autoinjector pen is self-administered into a woman’s abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day.
The bremelanotide is the first treatment for this patient population.
The FDA approval of the drug is based upon data from approximately 1,200 women in two pivotal, double-blind placebo-controlled phase 3 trials (RECONNECT).
In both clinical trials, bremelanotide met the pre- specified co-primary efficacy endpoints of improvement in desire and reductions in distress as measured by validated patient-reported outcome instruments.
Upon completion of the trial, women had the option to continue in a voluntary open-label safety extension study for an additional 12 months. Nearly 80 percent of patients who completed the phase 3 trials elected to remain in the open-label portion of the study, where all of these patients received bremelanotide.