Dec 30 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Monday it would seek marketing approval next year for its oral drug to treat agitation in patients with Alzheimer's disease ...
30, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics ... and aminoketone CYP2D6 inhibitor, in Alzheimer’s disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term safety trials ...
On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in Alzheimer's disease agitation.
Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term ...
Further, AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to the placebo. Also Read: Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In ...
Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term studies.
Additionally, AXS-05 was found to prevent worsening of overall Alzheimer's disease severity. According to InvestingPro data, Axsome has demonstrated impressive revenue growth of 51.47% over the ...
Agitation caused by Alzheimer’s disease currently has one FDA-approved therapy, but that drug brings serious safety risks. An Axsome Therapeutics drug has mixed results from its latest slate of ...
The study also showed AXS-05 reduced worsening for overall Alzheimer’s disease severity compared to placebo, Axsome (NASDAQ:AXSM) added. A Phase 3 study called ADVANCE-2, however, did not meet ...