Axsome posts presentation on FDA approval of Auvelity for Alzheimer’s agitation-associated dementia

Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc.

AXSM

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  • Axsome Therapeutics highlighted FDA clearance for AUVELITY to treat agitation associated with dementia due to Alzheimer’s disease, expanding label beyond major depressive disorder.
  • Prescribing information states AUVELITY is not indicated for as-needed use for Alzheimer’s-related agitation.
  • Axsome cited efficacy in short-term and long-term studies, including statistically significantly longer time to relapse.
  • Most common adverse reactions in Alzheimer’s-related agitation were dizziness and dyspepsia; discontinuation due to adverse events was 1.3%, matching placebo.
  • Label includes warnings on seizure risk, blood pressure increases, serotonin syndrome risk with SSRIs or tricyclics, and boxed warning on suicidal thoughts and behaviors for antidepressants in younger patients.


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