The U.S. Food and Drug Administration has approved an expanded indication for Auvelity, allowing its use to treat agitation associated with dementia due to Alzheimer’s disease in adults. The decision marks a notable milestone, as Auvelity becomes the first FDA-approved treatment for this condition that is not classified as an antipsychotic.
Developed by Axsome Therapeutics, Auvelity is a combination therapy consisting of dextromethorphan hydrobromide and bupropion hydrochloride in an extended-release formulation. The drug was initially approved in 2022 for the treatment of major depressive disorder in adults, and its expanded use now addresses one of the most challenging symptoms associated with Alzheimer’s disease.
Agitation in Alzheimer’s patients is a common and distressing condition, often characterized by excessive movement, irritability, or verbal and physical aggression. These symptoms can significantly affect not only patients but also caregivers and family members, frequently leading to increased healthcare burden and reduced quality of life.
Marty Makary described the approval as an important step forward in addressing complications of Alzheimer’s disease. He emphasized that patients and families now have access to an additional treatment option for a condition that has historically been difficult to manage.
The FDA’s decision was supported by data from two randomized clinical trials evaluating Auvelity’s effectiveness in reducing agitation symptoms. In the first study, a five-week placebo-controlled trial, patients treated with Auvelity showed significant improvement in agitation scores as measured by the Cohen-Mansfield Agitation Inventory, a widely used tool that assesses behavioral symptoms in elderly patients based on caregiver observations.
The second study focused on relapse prevention. Patients who initially responded to Auvelity were either continued on the therapy or switched to a placebo. Results demonstrated that those who remained on Auvelity experienced a significantly longer time before relapse of agitation symptoms compared to those receiving placebo, reinforcing the drug’s sustained benefits.
Tracy Beth Hoeg, Acting Director of the FDA’s Center for Drug Evaluation and Research, noted that the therapy offers a meaningful new option for managing agitation, particularly as Alzheimer’s disease progresses.
However, the treatment is not without risks. Common side effects include dizziness, headache, gastrointestinal issues, drowsiness, and dry mouth. The drug also carries a boxed warning regarding an increased risk of suicidal thoughts and behaviors in younger patients taking antidepressants. Additional risks include seizures, elevated blood pressure, and the potential to trigger manic episodes in susceptible individuals.
Healthcare providers are advised to carefully evaluate patients before initiating treatment, including assessing blood pressure and screening for a history of bipolar disorder or concurrent use of similar medications.
The FDA granted both Breakthrough Therapy and Priority Review designations for this application, underscoring the urgent need for effective treatments in this area.
This approval represents a significant advancement in Alzheimer’s care, offering a new therapeutic approach for managing agitation and improving the quality of life for patients and their caregivers.