FDA Grants Zuranalone Priority Review for Major Depressive Disorder, Post-partum Depression

A New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD) has been accepted by the US Food and Drug Administration (FDA) and the agency has granted the NDA priority review.

Zuranolone is an investigational oral neuroactive steroid with a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. The drug is being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD, according to a statement from codevelopers Sage Therapeutics and Biogen Inc.

An episode of MDD is estimated to have affected more than 21 million adults in 2020 and PDD cases are estimated at a half million annually, according to the statement.

Data included in the zuranolone NDA come from the LANDSCAPE and NEST clinical development programs. LANDSCAPE includes 5 studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). ROBIN and SKYLARK, the 2 placebo-controlled studies in the NEST prgroam, evaluated zuranolone in adult women with PPD.

Findings across the clinical trial programs demonstrated rapid and sustained improvements in depressive symptoms including increased scores on the Hamilton Rating Scale for Depression and the Montgomery–Åsberg Depression Rating Scale at study day 15. Zuranolone was generally well tolerated with somnolence, dizziness, headache, and sedation the most commonly reported treatment-emergent adverse events.

“We see potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD and PPD,” said Priya Singhal, MD, MPH, executive vice president, head of Development, interim head of Research and Global Safety and Regulatory Sciences at Biogen. “The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression.”

A Prescription Drug User Fee Act target date of August 5, 2023 has been set for the application.