In both phase 3 studies, bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire.
The US Food and Drug Administration (FDA) accepted AMAG Pharmaceuticals’ new drug application for bremelanotide, a first-in-class melanocortin 4 receptor agonist designed for treatment of hypoactive sexual desire disorder in premenopausal women.
The NDA submission was backed by clinical data from 2 large phase 3 studies in which bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire, measured by validated patient-reported outcomes.
In the acceptance letter, the FDA stated that it’s currently planning to hold an advisory committee meeting discussing the application.
“Women who experience diminished sexual desire report feeling like something is missing and experience distress as a result. They want to get their desire back but may not think to attribute its loss to a medical condition that can be treated, ” Julie Krop, MD, chief medical officer, executive vice president, medial development and regulatory affairs, AMAG, said in a statement. “AMAG is dedicated to further raising awareness of this common condition and offering patients and clinicians an innovative treatment option that can be given as desired rather than daily, due to its unique mechanism of action.”
Bremelanotide has been studied in more than 30 clinical trials with more than 2500 women.
The phase 3 RECONNECT studies, which consisted of 2 double-blind placebo-controlled, randomized parallel group studies, compared 1.75 mg of bremelanotide versus placebo, and in each case, was delivered via a subcutaneous auto-injector. Each trial included more than 600 patients, randomized in a 1:1 ratio with a 24-week evaluation period.
After completion of the trial, nearly 80% of the women opted to continue in an open-label safety extension study for an additional 52 weeks.
In the phase 3 trials, the most common side effects included nausea, flushing and headache, with a majority of events reported transient and mild-to-moderate in intensity.
The investigational product is thought to possess a novel mechanism of action which impacts the balance between inhibitory and excitatory neural pathways in the brain to restore sexual desire.
If approved, bremelanotide will be available as a self-administered, disposable subcutaneous auto-injector used in anticipation of a sexual encounter.
The prescription drug user fee act (PDUFA) goal date is set for March 23, 2019.