Dextromethorphan/Bupropion: First Approval
CNS Drugs October 27, 2022 DOI: 10.1007/s40263-022-00968-4 (opens in new tab) via Semantic Scholar
Summary
AI-generated from the abstractDextromethorphan/bupropion (Auvelity) is an oral, fixed-dose combination developed by Axsome Therapeutics for major depressive disorder, Alzheimer's disease agitation, and smoking cessation. Dextromethorphan is an NMDA receptor antagonist and sigma-1 receptor agonist; bupropion is an antidepressant and CYP2D6 inhibitor that increases dextromethorphan's bioavailability. The drug received US approval in August 2022 for treating MDD in adults. This article summarizes the development milestones leading to that approval, including clinical trials and regulatory steps.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Keywords | Medicine |
| Key finding | Argues that dextromethorphan/bupropion received US approval in August 2022 for treating MDD in adults, summarizing the development milestones. |
Abstract
An oral, fixed-dose combination of dextromethorphan hydrobromide [an uncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist] and the antidepressant bupropion hydrochloride (an aminoketone and CYP2D6 inhibitor that increases dextromethorphan bioavailability) [AUVELITYTM; dextromethorphan/bupropion], is being developed by Axsome Therapeutics, Inc. for the treatment of major depressive disorder (MDD), Alzheimer’s disease agitation and smoking cessation. Dextromethorphan/bupropion was approved in the USA in August 2022 for the treatment of MDD in adults. This article summarizes the milestones in the development of dextromethorphan/bupropion leading to this first approval for the treatment of adults with MDD.