FDA expands Auvelity use to Alzheimer’s-related agitation

Axsome Therapeutics said the US Food and Drug Administration approved an expanded indication for Auvelity to treat agitation associated with dementia due to Alzheimer’s disease in adults on April 30, 2026. That makes Auvelity the first FDA-approved non-antipsychotic for this use, and the second approved drug overall after Rexulti’s 2023 approval. Auvelity, a dextromethorphan-bupropion combination first cleared in 2022 for major depressive disorder, now carries labeling that includes a scheduled titration for Alzheimer’s-related agitation and notes that it isn’t intended for as-needed use. (fda.gov)

Why it matters: While this is a human drug development, it’s still relevant to veterinary professionals tracking neurobehavioral therapeutics, caregiver burden, and the broader CNS drug pipeline. The approval adds a mechanistically distinct option in a space long dominated by off-label approaches and antipsychotic risk-benefit debates. FDA said the decision was supported by two randomized trials, and the updated label lists dizziness and dyspepsia among the most common adverse reactions in the Alzheimer’s agitation population. Alzheimer’s Association leaders also emphasized that medication should complement, not replace, first-line non-pharmacologic strategies and individualized care planning. (fda.gov)

What to watch: Watch for launch uptake, payer coverage, and how clinicians position Auvelity alongside non-drug interventions and existing use of Rexulti. (fda.gov)