Breaking News: FDA Approves Zuranolone, a Pill for Postpartum Depression Treatment

By Rebecca Britt, MA

August 4, 2023, marked a significant milestone in the field of maternal mental health as the FDA approved zuranolone, marketed as ZURZUVAE™, a groundbreaking treatment for postpartum depression (PPD). This 14-day oral regimen, developed by Sage Therapeutics and Biogen Inc., demonstrated significant improvement in depressive symptoms in Phase III trials. ZURZUVAE is the first daily pill option available, increasing accessibility and convenience for those in need.

Zulresso, also developed by Sage Therapeutics, was the first postpartum depression-specific FDA-approved drug treatment. However, it is delivered intravenously and can be difficult to access, as well as costly.

The approval of ZURZUVAE, a once-daily, 14-day treatment, offers a new ray of hope for individuals experiencing postpartum depression and for prescribing providers. 

“Throughout the U.S., there have been significant shortages of mental health care providers, including providers qualified to treat maternal mental health conditions. It is absolutely game-changing that the mother’s Ob/Gyn or Midwife can now prescribe this new treatment without consulting or referring to a psychiatrist, and a mother is almost guaranteed to be well in two weeks,” said Joy Burkhard, Executive Director. 

It’s important to note that some mothers may still prefer mental health talk therapy over drug treatment. However, these mothers should now be able to see qualified therapists (those who are Perinatal Mental Health Certified) more quickly as demand should be lessened. 

At the Policy Center, we recognize the importance of expanding access to such vital treatments, and we are closely monitoring distribution and insurance coverage for ZURZUVAE. We will continue to provide relevant updates to the field regarding any barriers to accessing the drug.

August 8, 2023 Update:

Per officials at Sage Therapeutics, the Policy Center has learned:

  • ZURZUVAE is not currently available and is expected to be available only after scheduling by the U.S. Drug Enforcement Administration (DEA), which is anticipated to occur within 90 days.
  • There are no concerns over drug availability due to supply chain issues. 
  • Sage has indicated the goal is for the medication to be accessible to anyone with postpartum depression (PPD) who is prescribed it. This will be facilitated through patient access programs, including copay assistance for eligible adults with PPD who are commercially insured.
  • Payer decisions for the coverage of ZURZUVAE are expected to be made in the months after the US Drug Enforcement Administration’s scheduling of zuranolone as a controlled substance, which is anticipated to happen within 90 days.

The Policy Center will provide additional information about Medicaid and private insurance coverage as these details become available and once ZURZUVAE becomes available to prescribe.