FDA approves Axsome’s fast-acting treatment for major depression

After a lengthy review, the Food and Drug Administration approved a fast-acting depression treatment from Axsome Therapeutics on Friday, clearing the way for the first new oral therapy for major depressive disorder in decades.

The drug, to be sold as Auvelity, had a rapid and significant effect on major depression in a roughly 300-patient trial, outperforming placebo on a measure of depression symptoms after one week and sustaining the effect for another five. On average, patients taking Axsome’s drug charted a 15.9-point improvement on a 60-point scale of depression severity. That was a statistically significant result compared with the 12.1-point benefit seen on placebo.

Auvelity is a combination of dextromethorphan, commonly found in cough suppressants, and a generic form of the depression treatment Wellbutrin. Auvelity targets the brain’s NMDA receptors, which play a role in the formation of memories, and is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

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