The U.S. Food and Drug Administration (FDA) has approved an expanded use of Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. This marks the first FDA-approved non-antipsychotic medication for managing this challenging symptom of Alzheimer’s dementia.
Auvelity was originally approved in 2022 to treat major depressive disorder in adults. The new indication follows clinical trials demonstrating its efficacy in reducing agitation, which is characterized by excessive motor activity, verbal, or physical aggression in patients with Alzheimer’s dementia.
Clinical Evidence Supporting Approval
The FDA approval is based on findings from two randomized clinical trials. The first, a five-week study (NCT 03226522), compared Auvelity to placebo and measured agitation using the Cohen-Mansfield Agitation Inventory (CMAI), a caregiver-based assessment tool for agitated behaviors in elderly patients. Auvelity showed statistically significant improvement over placebo in reducing agitation scores.
The second trial (NCT 04947553) was a withdrawal study involving participants who initially responded to Auvelity. Patients were randomized to either continue the treatment or switch to placebo, with the primary endpoint being time to relapse of agitation symptoms. Those who remained on Auvelity experienced a significantly longer duration before relapse compared to placebo recipients.
Safety and Usage Considerations
Common side effects reported in the trials include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and uncontrolled sweating. Auvelity carries a Boxed Warning for increased risk of suicidal thoughts and behaviors in adolescents and young adults treated with antidepressants, necessitating close patient monitoring, especially during treatment initiation.
Additional risks include seizures with dose-related incidence, elevated blood pressure, and possible activation of mania or hypomania in patients with a history of bipolar disorder. Healthcare providers are advised to assess blood pressure, review personal and family psychiatric history, and evaluate concurrent use of medications containing bupropion or dextromethorphan before prescribing Auvelity.
Regulatory Context
The FDA granted breakthrough therapy and priority review designations to Auvelity for this indication, reflecting the significant need for new treatment options addressing agitation in Alzheimer’s disease dementia. The approval was granted to Axsome Therapeutics, the drug’s developer.
Why it matters
Agitation is a common and distressing symptom in Alzheimer’s dementia that can severely affect patient quality of life and caregiver burden. Prior to this approval, only antipsychotic drugs were available for treatment, despite known safety concerns with their use in elderly dementia patients. Auvelity’s approval provides a novel, non-antipsychotic alternative to manage these symptoms, potentially improving therapeutic options and outcomes for patients and families.
Sources
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