FDA Approves ‘Rapid-Acting’ Auvelity Oral Tablet For Major Depression

On August 19, 2022, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Auvelity, a rapid-acting extended-release oral combination of dextromethorphan hydrobromide (HBr) and bupropion hydrochloride (HCl), to treat adults with major depressive disorder (MDD). Auvelity targets the N-methyl D-aspartate (NMDA) receptor antagonist, which is the first new oral mechanism of action approved for treating MDD in 60 years. Compared to people with MDD who received a placebo, those taking Auvelity had a significant improvement in depressive symptoms during the first week. Axsome anticipates Auvelity to be commercially available in . . .