Axsome’s Wait Pays Off With Broad Auvelity Label For Major Depression

19 Aug 2022

After a year-long delay, Axsome gets US FDA approval of bupropion/dextromethorphan combo with broad label for major depression. Firm expects to launch in Q4 with pricing intended for broad patient access.

Major depressive disorder — Axsome thinks differentiated label will help Auvelity compete in genericized market • Source: Shutterstock

An approval decision was delayed nearly a year, but Axsome Therapeutics, Inc. got good news on 19 August with the US Food and Drug Administration approval of Auvelity (AXS-05) for adults with major depressive disorder. The company and analysts noted the product’s broad label – including Phase III trial data showing quick onset of action – and shareholders responded positively, as Axsome’s stock price rose 40% in same-day trading.

Auvelity, which combines 105mg of bupropion and 45mg of dextromethorphan, is the first oral N-methyl D-aspartate (NMDA) receptor modulator approved...