The Medical Letter on Drugs and Therapeutics
- Dextromethorphan/Bupropion (Auvelity) for Depression
- Dexmedetomidine Sublingual Film (Igalmi) for Acute Agitation
- Risankizumab (Skyrizi) - An IL-23 Antagonist for Crohn's Disease
- In Brief: Oral Minoxidil for Hair Loss
- COVID-19 Update: Bebtelovimab EUA Withdrawn (online only)
- 2022 Annual Index (Online Only)
Dextromethorphan/Bupropion (Auvelity) for Depression
December 26, 2022 (Issue: 1666)The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.
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- Drugs for depression. Med Lett Drugs Ther 2020; 62:25.
- A new indication for esketamine nasal spray (Spravato). Med Lett Drugs Ther 2020; 62:151.
- DV Iosifescu et al. Efficacy and safety of AXS-05 (dextromethorphan-bupropion) in patients with major depressive disorder: a phase 3 randomized clinical trial (GEMINI). J Clin Psychiatry 2022; 83:21m14345.
- H Tabuteau et al. Effect of AXS-05 (dextromethorphan-bupropion) in major depressive disorder: a randomized double-blind controlled trial. Am J Psychiatry 2022; 179:490.
- Axsome Therapeutics, Inc. News Release. Axsome Therapeutics announces topline results of the STRIDE-1 phase 3 trial in treatment resistant depression and expert call to discuss clinical implications. March 30, 2020. Available at: https://bit.ly/3VLIrUP. Accessed December 8, 2022.
- Axsome Therapeutics, Inc. News Release. Axsome Therapeutics announces AXS-05 achieves primary endpoint in the ACCORD phase 3 trial in Alzheimer’s disease agitation. November 28, 2022. Available at: https://bit.ly/3gUHivh. Accessed December 8, 2022.
- M Fornaro et al. The FDA “black box” warning on antidepressant suicide risk in young adults: more harm than benefits? Front Psychiatry 2019; 10:294.
- Inhibitors and inducers of CYP enzymes, P-glycoprotein, and other transporters. Med Lett Drugs Ther 2021 October 20 (epub). Available at: medicalletter.org/downloads/CYP_PGP_Tables.pdf.
- AF Schatzberg. Understanding the efficacy and mechanism of action of a dextromethorphan-bupropion combination: where does it fit in the NMDA versus mu-opioid story? Am J Psychiatry 2022; 179:448.
- Approximate WAC for 30 days’ treatment at the usual dosage. WAC = wholesaler acquisition cost or manufacturer’s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. December 5, 2022. Reprinted with permission by First Databank, Inc. All rights reserved. ©2022. www.fdbhealth.com/policies/drug-pricing-policy.
The Medical Letter is a subscriber-funded nonprofit organization that publishes critical appraisals of new prescription drugs and comparative reviews of drugs for common diseases.