FDA Will Not Hold Advisory Meeting for MDD, PPD Drug Application

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced the agency does not plan on holding an advisory committee meeting for the New Drug Application (NDA) for zuranolone, an investigational drug for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

The treatment, developed by Biogen and Sage Therapeutics, is being evaluated as a 14 day, rapid-acting, once-daily, oral treatment for adult patients with MDD and PPD. The drug is an oral neuroactive steroid GABA-A receptor positive allosteric modulator.

The FDA application is based on both the LANDSCAPE and NEST clinical programs, which involve multiple studies exploring the treatment in a variety of dosing, clinical endpoints, and treatment paradigms.

The LANDSCAPE program is a 5 study series for patients with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL).

The NEST program is a pair of studies for women with PPD (ROBIN and SKYLARK).

There is currently a Prescription Drug User Fee Act (PDUFA) action date set for August 5, 2023 for the application, which was granted priority review.

In an interview with HCPLive at presented at the American Psychiatric Association (APA) 2022 Annual Meeting in New Orleans, poster presenter Anita Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, discussed the details of the zuranolone clinical trial program for patients with PPD or MDD—populations which for some time have needed more novel therapies.