My Alzheimer's Journey
Part 143 - Auvelity - A New Drug For The Treatment Of Agitation Associated With Alzheimer's Disease
On April 30, Axsome Therapeutics’s Auvelity got full approval from the Food and Drug Administration (FDA), becoming the second medication approved for treating agitation related to Alzheimer’s. Unlike the antipsychotic Rexulti (generic name: brexpiprazole), which was approved in 2024 after showing a small benefit on agitation symptoms, it doesn’t seem to increase mortality risk. Rexulti carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis.
Auvelity was approved in August 2022 for treating major depressive disorder (MDD) in adults. Major depressive disorder affects an estimated 280 million people globally and is a leading cause of disability worldwide. Auvelity has shown to start working for some people as early as one week. To date, Auvelity has been administered to more than 300,000 patients.
Auvelity is a combination of two medications, dextromethorphan and bupropion. These two drugs affect brain pathways responsible for mood regulation and stress responses, two networks thought to be involved in the agitation-related behavioral changes associated with Alzheimer’s.
Auvelity is not to be taken on an as needed basis. Dosing will be gradually increased over time depending on the patient tolerability. Patients start with 30 mg/105 mg (dextromethorphan 30 mg/bupropion 105 mg) once daily for 7 days, increase to twice daily on Day 8, and may reach the maximum dose of 45 mg/105 mg twice daily by Day 15.
Many physicians are less than enthusiastic about Auvelity as treatment for agitation related to Alzheimer’s. They have concerns about Axsome’s delayed release of data, and Auvelity’s lack of peer-reviewed studies. Axsome ran four Phase 3 trials to show its efficacy, though the data for most of the trials are not yet published in peer-reviewed scientific journals.
In 2020, the company shared data from the first trial showing a modest reduction in agitation. Some researchers suggest this small change would not be noticeable by patients and caregivers.
In 2022, data from the second Phase 3 trial was released by Axsome. That study involved following people who responded well to the drug, and then for half of the participants, replacing the active treatment with a placebo to see when symptoms return. That study showed people continuing to take the drug were less likely to experience a relapse in symptoms.
These two studies were the basis for FDA approval April 30.
Overall, the effect of Auvelty for treatment of agitation related to Alzheimer’s has been characterized by some physicians as modest. Yet, Auvelty is considered a much safer drug than Ruxelti; thus giving it an advantage. The most common side effects were dizziness, headache, and nausea and the drug didn’t seem to increase the risk of mortality.
So far, none of the agitation drugs on the market show a very large effect on symptoms. Non-pharmaceutical interventions seem to be the best front-line treatment. Caregivers know what works best for their loved one or patient, for example, music, a calm environment, or limited distractions. Auvelty may be worth trying for several months to see if it is effective.
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