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FDA Approves Non-Antipsychotic Alzheimer's Treatment
13 May
Summary
- FDA green-lights first non-antipsychotic drug for Alzheimer's agitation.
- Auvelity targets agitation, a common and distressing symptom in dementia.
- Drug trials showed significant improvement in agitated behaviors.
The U.S. Food and Drug Administration (FDA) has approved Auvelity as the first non-antipsychotic drug treatment for agitation in Alzheimer's disease patients. This condition, marked by aggression and excessive motor activity, is a common and distressing symptom.
Agitation significantly affects the quality of life for both patients and their caregivers. The FDA noted this approval represents a major advancement in managing a challenging aspect of Alzheimer's disease.
Two randomized trials confirmed Auvelity's effectiveness. The first study showed significant improvements in agitated behaviors. The second trial demonstrated that patients continuing Auvelity experienced a longer delay before agitation symptoms returned compared to those on placebo.
Auvelity, administered in extended-release tablets, works on NMDA and sigma-1 receptors to reduce agitation and depression. Dr. Marc Siegel highlighted its benefits over antipsychotics, noting fewer side effects like drowsiness and better cardiovascular tolerance.
Healthcare providers must monitor patients' blood pressure and screen for bipolar disorder or concurrent use of bupropion or dextromethorphan. Common side effects include dizziness, headache, and dry mouth. Serious risks involve seizures, elevated blood pressure, mania, and increased suicidal thoughts in younger adults.
