FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
The FDA approved an expanded indication for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets for the treatment of agitation associated with Alzheimer’s dementia in adults.
This affects the manufacturer of Auvelity, healthcare providers treating Alzheimer's patients, and regulatory professionals managing labeling and compliance for neuropsychiatric medications.
The source notes this is the first non-antipsychotic drug approved for this specific indication. Professionally, this indicates a shift in the regulatory landscape for dementia-related agitation treatments, potentially providing a new therapeutic class for patients who might otherwise be treated with off-label or antipsychotic medications. It suggests the FDA's willingness to approve existing multi-mechanistic formulations for specialized geriatric behavioral symptoms.
Regulatory and clinical teams should review the updated prescribing information for Auvelity to ensure compliance with the expanded indication. Pharmacovigilance departments should monitor post-marketing safety data specifically within the Alzheimer’s patient population.
The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults.
Open in openFDA / FDA.gov