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FDA approves Axsome first rapid-acting antidepressant

New York-based biopharma Axsome Therapeutics announced last week that the FDA had approved Auvelity, its oral n-methyl d-aspartate (NDMA) receptor drug developed to treat the major depressive disorder in adults.

Auvelity is the first and only NDMA receptor antagonist approved for the disorder, and Axsome says it sets itself apart from other antidepressants on the market by acting quicker than most.

“In clinical trials, Auvelity has demonstrated rapid and statistically significant improvement in depressive symptoms as early as Week 1, and increased rates of remission at Week 2 compared with placebo,” said Ian V. Iosifescu, MD, professor of psychiatry at the New York University School of Medicine.

Iosifescu also went on to explain that because the drug “targets glutamatergic neurotransmission, [Auvelity] provides clinicians with a long sought after new mechanistic approach which may benefit the millions of patients living with this serious condition.“

The FDA initially granted Breakthrough Designation for the drug in March of 2019. Based on results from the Gemini placebo-controlled study, which included more than 1,100 patients with depression.

Axsome anticipates Auvelity to be commercially available in the U.S. in the fourth quarter of 2022.