Oral Postpartum Depression Drug Zurzuvae Launches

Biogen and Sage Therapeutics have launched Zurzuvae (zuranolone), the first oral therapy to treat women with postpartum depression. The companies said they are in discussions with payers, including commercial insurers and Medicaid.

A spokesperson for Biogen said the companies actively working with payers to help coverage policies start to become available beginning in in the first half of 2024. “What we’ve heard from payers is that they understand the urgent and unmet need for the treatment of women with postpartum depression,” the spokesperson said. “They believe Zurzuvae can be a significant advancement in the treatment of postpartum depression, with the potential to be a first line therapy.”

In an investor call in November 2023, Chris Benecchi, chief business officer of Sage, said they had completed more than 100 “engagements” with health plan and PBM customers.

While coverage decisions are being made by insurers, Biogen and Sage have launched a patient support program, Zurzuvae For You, which provides educational resources, help with understanding insurance coverage, and assistance navigating the prescription fulfillment process. The program also includes financial assistance, such as a $0 copay assistance and financial assistance for women with postpartum depression who are prescribed Zurzuvae.

Zurzuvae is a rapid-acting neuroactive steroid that targets the GABA-A receptor and is a controlled substance, designated as Schedule IV by the Drug Enforcement Administration. It will have a wholesale acquisition cost of $15,900 for a 14-day course of treatment. Benecchi said the price reflects the innovation, clinical value and impact of Zurzuvae on women with postpartum depression. Women with PPD have more hospital admissions and overall higher healthcare resource utilization and health expenditures than women who do not have PPD, he said.

Postpartum depression is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment was only available as an IV injection given by a healthcare provider.

Related: FDA Approves Oral Treatment for Postpartum Depression

The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Zurzuvae targets brain networks responsible for functions such as mood, arousal, behavior, and cognition. It is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function.

Kristina M. Deligiannidis, M.D.

“For women with PPD, delayed improvement in depressive symptoms can significantly worsen outcomes. Having an option like Zurzuvae that can work at day 15 and improve symptoms in as early as three days has the potential to make a profound difference in the lives of women with PPD,” Kristina M. Deligiannidis, M.D., a principal investigator in the Zurzuvae clinical development program and professor, The Feinstein Institutes for Medical Research in Manhasset, New York, said in a press release.