FDA Approves Rapid-Acting Drug for Major Depression
Biogen and Sage Therapeutics have announced that the U.S. Food and Drug Administration (FDA) has accepted New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, oral treatment in adults with MDD and PPD.
“We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. 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.” said Laura Gault, M.D., Ph.D., Chief
Medical Officer at Sage.
Depression is one of the most common psychological disorders worldwide. It is estimated that in excess of 21 million adults in the U.S. experienced at least one major depressive episode in 2020, with nearly 14 million people diagnosed with major depressive disorder, and an estimated 500,000 cases of PPD annually.
Symptoms of MDD and PPD have been demonstrated to have an impact on a person’s overall quality of life and well-being. In 2018, the incremental economic burden of MDD was an estimated $326 billion in the U.S. alone.
Zuranolone, a neuroactive steroid, has a new mechanism of action as a positive allosteric modulator of GABA-A receptors. It is thought to function in depressed individuals by quickly rebalancing dysregulated neuronal networks to assist in resetting brain function. Zuranolone concentrates on the brain regions that control mood, arousal, behavior, and cognition.
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