FDA accepts application for zuranolone to treat depression

The FDA has accepted a new drug application for zuranolone as a rapid-acting, once-daily, 14-day, oral treatment of postpartum depression and MDD, according to a release from the manufacturers.

Zuranolone (Biogen/Sage Therapeutics) is a neuroactive steroid with a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. The drug is meant to rapidly rebalance dysregulated neuronal networks to reset brain function and target networks responsible for function.

The application has been granted priority review and has been assigned a Prescription Drug User Fee Act action date of Aug. 5, the companies said.

“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed,” Sage chief medical officer Laura Gault, MD, PhD, said in the release. “Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly. We believe zuranolone, if approved, could offer a new way for physicians to support patients.”