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The U.S. Food and Drug Administration has green-lit the first-ever non-antipsychotic drug treatment for agitation in Alzheimer’s disease patients.
The drug, Auvelity, was originally FDA-approved in 2022 for treating adults with major depressive disorder. Most recently, its use has been expanded for agitation associated with dementia.
Agitation is a common and “distressing” symptom in adults with Alzheimer’s, according to the agency. The condition is characterized by excessive motor activity, or verbal or physical aggression.
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The FDA noted that agitation can “significantly impact quality of life for patients and caregivers.”
In a press release, the FDA commissioner commented that this approval “represents a significant advancement in our ability to help patients and families dealing with 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.
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Tracy Beth Hoeg, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research, also reflected on the approval, noting that Auvelity was found to be “efficacious for treating agitation in Alzheimer’s disease” in two randomized trials.
The first study was a five-week trial of the drug, in which patients were assessed for the frequency of agitated behaviors based on caregiver reports. The results found Auvelity, which is made by Axsome Therapeutics in New York City, to be “significantly superior” in improving behaviors.
The second study looked at patients who responded to Auvelity and were then randomly assigned to continue treatment or switch, tracking how long it took for agitation symptoms to return.
Participants who continued Auvelity reported significantly longer time periods before relapse compared to those receiving placebo treatment.
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“[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 is administered in rapid-onset extended-release tablets. The FDA urged healthcare providers to monitor blood pressure, screen for a medical history of bipolar disorder, and determine whether patients are taking other medications that contain bupropion or dextromethorphan before prescribing Auvelity.
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The most common side effects of the medication include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction and uncontrolled sweating, according to the FDA.
The treatment can also cause seizures, with the risk increasing along with the dose. Other risks include elevated blood pressure, hypertension and mania in susceptible patients.
The drug’s prescribing information also warns of increased suicidal thoughts in younger adults; providers should monitor patients for the emergence of these behaviors, the FDA advised.
CALLOUT: “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.”
Fox News senior medical analyst Dr. Marc Siegel applauded this approval in an interview with Fox News Digital.
The doctor said the treatment works on two brain targets — NMDA and sigma-1 receptors — helping to reduce agitation and depression in older adults with dementia, including Alzheimer’s patients.
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“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 … and is much better tolerated by the heart in a very old person,” Siegel added.
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