FDA Approves Auvelity for Agitation in Alzheimer’s Disease - Takeaways - MDSpire
FDA & Government News

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

The oral combination therapy expands treatment options for agitation associated with dementia due to Alzheimer’s disease.

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    Dextromethorphan-bupropion approved for Alzheimer's agitation.

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    Agitation seen in up to 76% of Alzheimer's patients.

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    Phase 3 trials showed significant symptom improvement.

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    Initial dosing: 30 mg/105 mg once daily; adjust as tolerated.

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    Monitor for side effects, especially in older adults.

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    Boxed warning for suicide risk and other serious adverse effects.

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    Not for as-needed use in agitation treatment.

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    Previous approval for major depressive disorder.

Original Source(s)

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

  • by Kathryn Wighton

  • April 30, 2026

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