AMAG Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for bremelanotide, which AMAG in-licensed from Palatin Technologies, Inc. in February 2017. 

Bremelanotide is a first-in-class melanocortin 4 receptor agonist developed to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It has a novel mechanism of action that activates the endogenous melanocortin pathways in the brain involved in the body’s normal sexual desire and arousal responses. If approved, this new treatment will be available as a subcutaneous self-injection in a prefilled disposable auto-injector pen for use in anticipation of a sexual encounter.

“Today’s NDA submission represents a continuation of AMAG’s commitment to support patients with unmet medical needs, and in particular it underscores our commitment to women’s health,” said Julie Krop, M.D., chief medical officer and executive vice president of clinical development and regulatory affairs at AMAG. “We are excited by the prospect of introducing a new treatment option to premenopausal women who suffer from HSDD.”

HSDD is the most common type of Female Sexual Dysfunction affecting an estimated 12 million women in the United States. 

AMAG’s NDA submission is supported by clinical data from two Phase 3 trials in which bremelanotide met the pre-specified co-primary endpoints of improvement in desire and decrease in distress as measured by validated patient-reported outcomes. The most common adverse events were nausea, flushing and headache. The majority of events were reported to be mild-to-moderate in intensity and transient.