-- Axsome Therapeutics (AXSM) said Thursday the US Food and Drug Administration approved Auvelity for the treatment of agitation associated with Alzheimer's disease dementia.
The approval was supported by two phase 3 clinical trials that showed the drug significantly improved agitation symptoms and resulted in a longer time to relapse compared with placebo.
The medication acts on N-methyl-D-aspartate and sigma-1 receptors in the brain and is also approved for adults with major depressive disorder, the company added.
Shares of Axsome were up more than 12% in Thursday trading.
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