FDA Accepts New Drug Application for Zuranolone

FDA Approves Fast-Acting Major Depression Drug Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted their new drug application for zuranolone, intended for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is a fast-acting drug for adults with MDD and PPD, designed for once-daily oral administration and currently in clinical trials. Laura Gault, M.D., Ph.D., Chief Medical Officer at Sage, stated: "We feel an enormous responsibility to offer patients with MDD and PPD a much-needed potential new treatment option. Most currently approved treatments can take weeks or months to take effect. We are committed to developing treatments that can rapidly address depression symptoms and help doctors and patients. If zuranolone is approved, we believe it could offer doctors a new way to support their patients." Depression is one of the most common psychological disorders worldwide. In the United States, more than 21 million adults experienced at least one major depressive episode in 2020, approximately 14 million people have been diagnosed with major depressive disorder, and an estimated 500,000 cases of PPD occur annually. MDD and PPD symptoms have been shown to have a significant impact on a person's overall quality of life and well-being. In 2018, the additional economic burden of MDD was estimated at approximately USD 326 billion in the United States alone. Zuranolone, a neuroactive steroid, has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. It is thought that zuranolone works by rapidly rebalancing dysregulated neuronal networks to help restore brain function in depressed individuals. Zuranolone targets brain regions that control mood, arousal, behavior, and cognition. Source