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# Rapid-Acting Depression Drug Gets Priority Review
- URL: https://www.fdaweb.com/rapid-acting-depression-drug-gets-priority-review/
- Published: 2023-02-06T12:00:00.000Z
- Updated: 2026-09-14T18:14:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153714

FDA has accepted for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major depressive disorder (MDD) and postpartum depression (PPD). The agency has set a user fee review action target date of 8/5.

“Most current approved therapies may take weeks or months to work,” the companies say. Zuranolone is being evaluated as a 14-day, rapid-acting, once-daily treatment. “We believe zuranolone, if approved, could offer a new way for physicians to support patients,” they add.

The submission includes data from the LANDSCAPE and NEST clinical development programs as well as a Phase 2 study of zuranolone completed by Shionogi in Japan in adults with MDD. The LANDSCAPE program includes five studies of zuranolone in adults with MDD (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). The NEST program includes two studies of zuranolone in adult women with PPD (ROBIN and SKYLARK).

The companies says zuranolone is a neuroactive steroid and has a “novel mechanism of action as a positive allosteric modulator of GABA-A receptors. In people with depression, it is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function.”