First oral medicine for postpartum depression approved

The US Food and Drug Administration (FDA) has approved Zurzuvae (zuranolone), the first oral medicine to treat postpartum depression (PPD) in adults. Historically, treatment for PPD has been only available as an IV injection.

“The FDA approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” commented Christopher Viehbacher, President and Chief Executive Officer at Biogen.

Based on clinical data, this treatment option has potential to provide “rapid improvements in depressive symptoms in as early as three days for women with postpartum depression,” explained Dr Kristina Deligiannidis, a Principal Investigator in the Zurzuvae clinical development programme and Professor at The Feinstein Institutes for Medical Research, US.

FDA approval of Zurzuvae for postpartum depression was granted to Sage Therapeutics, Inc. The once-daily, 14-day, 50mg treatment is expected to be commercially available in the fourth quarter of 2023.

Evidence of efficacy for postpartum depression

Basis of the FDA approval

The FDA’s approval was based on a series of clinical studies. In Study 1, patients received 50mg of Zurzuvae or a placebo once per day for two weeks. In Study 2, patients received another zuranolone product that was approximately equal to 40mg of Zurzuvae or placebo, also for 14 days.

Postpartum depression patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to given a placebo treatment. The treatment effect was maintained at Day 42—four weeks after the last dose of Zurzuvae.

In the SKYLARK study, part of the NEST clinical development programme evaluating Zurzuvae for postpartum depression, data showed a significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45.

FDA complete response letter for MDD

Additionally, the FDA has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Zuranolone as a treatment of adults with major depressive disorder (MDD). The letter stated that the application did not provide substantial evidence of effectiveness to support the FDA approval of Zuranolone for treating MDD; additional study or studies will be needed.

Along with Sage Therapeutics, Biogen is planning to “thoroughly review the feedback from the FDA on the use of Zuranolone in MDD to determine next steps,” Viehbacher added.