FDA Approves First Non-Antipsychotic Drug for Agitation in Alzheimer’s Patients

The U.S. Food and Drug Administration approved Auvelity on Thursday as the first non-antipsychotic drug for treating agitation in Alzheimer’s disease patients.

Auvelity gained initial FDA approval in 2022 for adults with major depressive disorder. The agency has now expanded its use to address agitation linked to dementia.

Agitation affects many adults with Alzheimer’s and ranks as a distressing symptom, the FDA said. It involves excessive motor activity or verbal and physical aggression.

The agency added that agitation significantly affects quality of life for patients and caregivers.

FDA Commissioner Robert M. Califf said in a press release that the approval marks a significant advancement in helping patients and families manage one of the most challenging aspects of Alzheimer’s disease. "With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease," he said.

Tracy Beth Hoeg, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research, said Auvelity proved efficacious for agitation in Alzheimer’s across two randomized trials.

The first trial lasted five weeks. Caregivers reported on the frequency of agitated behaviors, and Auvelity, made by Axsome Therapeutics in New York City, showed significantly superior results in improving them.

In the second trial, patients who responded to Auvelity received either continued treatment or a placebo. Those on the drug experienced significantly longer periods before agitation symptoms returned.

"[This approval] now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses," Hoeg said in a statement. "We hope this approval will provide meaningful benefit to patients, their families and caregivers."

Auvelity comes in rapid-onset extended-release tablets. The FDA advised healthcare providers to monitor blood pressure, check for bipolar disorder history and review other medications containing bupropion or dextromethorphan before prescribing.

Common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction and uncontrolled sweating. The drug can trigger seizures, with risk rising by dose. It also carries risks of elevated blood pressure, hypertension and mania in susceptible patients.

Prescribing information warns of increased suicidal thoughts in younger adults. Providers should watch for such behaviors.

"It is a good choice [over] anti-psychotics in many cases, because it doesn't cause the same amount of drowsiness or other side effects," said Fox News senior medical analyst Dr. Marc Siegel in an interview with Fox News Digital.

Siegel explained that Auvelity targets NMDA and sigma-1 receptors in the brain to reduce agitation and depression in older adults with dementia, including Alzheimer’s patients.