Axsome agrees to post-marketing commitments with FDA, signaling potential OK for long-delayed depression drug
Axsome Therapeutics is likely on the cusp of its first drug approval, sending shares of its stock up more than 40% pre-market on Tuesday.
The company said in an SEC filing Tuesday that it has agreed to certain postmarketing requirements/commitments proposed by the FDA with respect to the company’s application for AXS-05 for the treatment of major depressive disorder.
That application has been delayed since August, with the company receiving a letter outlining how FDA-identified deficiencies preclude labeling discussions with Axsome.
Delaying the inevitable? Axsome says FDA review going beyond PDUFA date
While that letter usually signals a complete response letter is in the books, the company’s agreement on postmarketing commitments seems to indicate otherwise.
The company did not speculate on an approval but said that based on this interaction, it anticipates potential FDA action on the NDA in the second quarter of 2022.
Wall Street analysts previously projected about $1.3 billion in peak sales for AXS-05, which is a combination of the cough suppressant dextromethorphan and the antidepressant bupropion. The once-failed experimental drug has received breakthrough designations from the FDA as a treatment for major depressive disorder and Alzheimer’s disease agitation, and the company is also developing it as a treatment for smoking cessation.
In Alzheimer’s agitation, it scored statistically significant results in a pivotal Phase II/III trial, but a path forward isn’t so straightforward.
April 21, 2022
