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The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator. It is intended for rapid, once-daily treatment of MDD and PPD and is taken for 14 days.
The NDA is supported by data from the LANDSCAPE and NEST clinical development programs. The LANDSCAPE program included 5 studies evaluating zuranolone in adults with MDD: MDD-201B (ClinicalTrials.gov Identifier: NCT03000530), MOUNTAIN (ClinicalTrials.gov Identifier: NCT03672175), SHORELINE (ClinicalTrials.gov Identifier: NCT03864614), WATERFALL (ClinicalTrials.gov Identifier: NCT04442490), and CORAL (ClinicalTrials.gov Identifier: NCT04476030).
The NEST program included 2 studies evaluating zuranolone in adult women with PPD: ROBIN (ClinicalTrials.gov Identifier: NCT02978326) and SKYLARK (ClinicalTrials.gov Identifier: NCT04442503).
Findings across both clinical programs showed that treatment with zuranolone led to rapid and sustained improvement in depressive symptoms as measured by the 17-item Hamilton Anxiety Rating Scale (HAMD-17) total score at day 15 (primary endpoint). Zuranolone was found to be generally well tolerated; somnolence, dizziness, headache, and sedation were 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 and 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.
Reference
Sage Therapeutics and Biogen announce FDA accepts filing of New Drug Application and grants Priority Review of zuranolone in the treatment of major depressive disorder and postpartum depression. News release. Sage Therapeutics and Biogen. Accessed February 6, 2023. https://www.businesswire.com/news/home/20230205005025/en/Sage-Therapeutics-and-Biogen-Announce-FDA-Accepts-Filing-of-New-Drug-Application-and-Grants-Priority-Review-of-Zuranolone-in-the-Treatment-of-Major-Depressive-Disorder-and-Postpartum-Depression.
