Postpartum Depression Drug Application Heads to FDA
Sage Therapeutics has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for its proposed postpartum depression (PPD) treatment, the biopharmaceutical company announced.
The drug is an intravenous formulation of brexanolone, formerly called SAGE-547. It received Breakthrough Therapy Designation from the FDA for PPD in September 2016, and would become the first drug approved specifically for PPD.
The NDA submission—the first for Sage Therapeutics— is based on 3 trials analyzing the safety and effectiveness of brexanolone in postpartum women aged 18 to 45 with moderate or severe PPD. The studies were known as the Hummingbird Program.
Positive phase 3 results from 2 of those studies were announced in November 2017. They showed the drug was associated with significantly lower depression scores, compared with placebo, at 60 hours after dosing in 126 patients with moderate or severe PPD, the company reported at the time. Results were maintained to 30 days.
Brexanolone, an allosteric modulator of synaptic and extrasynaptic GABAA receptors, is the lead product candidate for Sage Therapeutics, based in Cambridge, Massachusetts. The company focuses on developing novel medicines for life-altering central nervous system (CNS) disorders.
An estimated 11.5% of new mothers in the US experience PPD, and suicide is the leading cause of maternal death following childbirth, according to a company press release.