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Auvelity becomes first non-antipsychotic approved for Alzheimer’s agitation
Auvelity targets the NMDA and sigma-1 receptors, providing the first non-antipsychotic treatment option for Alzheimer’s patients with agitation. The approval of Auvelity was based on two Phase III trials: ADVANCE-1 (NCT03226522) and ACCORD-2 (NCT04797715). Caring for Alzheimer’s patients can be difficult, especially as patients advance into the more severe stages of the disease. Credit: Chinnapong via Shutterstock.com. On 30 April 2026, Axsome Therapeutics announced the FDA approval of Auvelity (dextromethorphan + bupropion) for the treatment of agitation associated with dementia due to Alzheimer’s disease, following a breakthrough therapy designation granted in 2020. Auvelity targets the N-methyl D-aspartate (NMDA) and sigma-1…
Auvelity targets the NMDA and sigma-1 receptors, providing the first non-antipsychotic treatment option for Alzheimer’s patients with agitation.
Source: Clinical Trials Arena