Presented with upbeat Alzheimer's agitation data, FDA sees another 'breakthrough' in Axsome's AXS-05
Axsome Therapeutics’ surprise win in a late-stage Alzheimer’s study, unveiled just two months ago, has registered with regulators. The New York-based biotech has notched a breakthrough therapy designation for AXS-05 for the indication, its second after major depressive disorder.
So what’s the big deal here? The drug is an oral agent “with multimodal activity” consisting of two components: dextromethorphan, an NMDA receptor antagonist, and bupropion — whose main purpose is to slow down the metabolism of the former.
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