FDA Grants Approval to Axsome’s Auvelity for Major Depressive Disorder

The FDA has approved Axsome Therapeutics’ Auvelity (dextromethorphan HBr -bupropion HCl) extended-release tablets for treatment of adult patients with major depressive disorder.

The rapid-acting drug has demonstrated the ability to reduce clinical depression in one week and the effects are sustained, the company said.

Auvelity binds to N-methyl D-aspartate (NMDA) receptors and inhibits NMDA. The drug’s exact mechanism of action in the treatment of depression is unclear.

The drug received FDA’s Breakthrough Therapy designation for the treatment of major depressive disorder in March 2019. Axsome said the drug will be available in the U.S. in the fourth quarter of this year.