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

 
• By Joseph Haas

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 for MDD, the company noted, making it the first new oral mechanism of action approved for depression in more than 60 years

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