AXS-05: an investigational treatment for Alzheimer's disease-associated agitation.
Kristen Ward, Leslie Citrome
Expert Opinion on Investigational Drugs August 2022 DOI: 10.1080/13543784.2022.2096006 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Population | Patients with Alzheimer's disease and agitation |
| Interventions | Dextromethorphan Bupropion |
| Keywords | Agitation Alzheimer’s disease Aggression Bupropion Dextromethorphan Pharmacodynamics Pharmacokinetics |
| Key findings | Early released clinical trial data indicate that AXS-05, a combination of dextromethorphan and bupropion, may be a useful option for treating agitation in patients with Alzheimer's disease and appears generally well tolerated. The authors suggest it may be especially helpful for patients with comorbid depression, drawing on separate Phase III studies of the compound in depression. |
Abstract
Agitation is common in patients with Alzheimer's disease (AD). Although nonpharmacologic de-escalation strategies are recommended as first-line treatment, medication is often needed to treat agitation. Currently, there are no FDA-approved medications for this indication. Psychotropics used to treat agitation include antipsychotics, which are notable for their efficacy but also their potential to cause serious side effects. AXS-05, a combination of dextromethorphan and bupropion, is currently being investigated for this indication. This review will discuss the pharmacology of AXS-05 and available clinical trial results from completed Phase I and Phase II/III studies assessing the potential for this compound to treat agitation in patients with AD. Ongoing research investigating AXS-05 for this indication will also be highlighted. Resources used for this review include PubMed, Embase, clinicaltrials.gov, and literature available on the manufacturer's website. Early released clinical trial data indicate that AXS-05 may be a useful option to treat agitation in patients with AD and that it appears to be generally well tolerated. AXS-05 may be especially helpful for patients with comorbid depression, when considering available data from separate phase III studies assessing the efficacy and safety of this compound in the treatment of depression.