The U.S. Food and Drug Administration has approved the first ever non-antipsychotic drug to treat agitation in Alzheimer’s disease patients.
The drug, Auvelity, was originally approved in 2022 for major depressive disorder. Now, its use has been expanded to treat agitation associated with dementia, a common and distressing symptom marked by excessive motor activity or aggression.
The FDA noted that agitation can significantly impact quality of life for patients and caregivers. In two randomized trials, Auvelity was found to be efficacious for treating agitation in Alzheimer’s disease.
The first study assessed the frequency of agitated behaviors based on caregiver reports over five weeks. Results showed Auvelity was significantly superior in improving behaviors. The second study found that patients who continued treatment experienced longer periods before relapse compared to those on placebo.
Auvelity, made by Axsome Therapeutics in New York City, is administered as rapid onset extended release tablets. Common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and uncontrolled sweating. The drug can also cause seizures and increased blood pressure.
Fox News senior medical analyst Dr. Marc Siegel called the approval a good choice over antipsychotics because it does not cause as much drowsiness or other side effects and is better tolerated by the heart in older patients. The treatment works on two brain targets, NMDA and sigma 1 receptors, helping to reduce agitation and depression.