Skip to main content

Auvelity FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 23, 2022.

FDA Approved: Yes (First approved August 18, 2022)
Brand name: Auvelity
Generic name: dextromethorphan and bupropion
Dosage form: Extended-Release Tablets
Previous Name: AXS-05
Company: Axsome Therapeutics, Inc.
Treatment for: Major Depressive Disorder

Auvelity (dextromethorphan and bupropion) is an NMDA receptor antagonist for the treatment of major depressive disorder (MDD) in adults.

  • The dextromethorphan component of Auvelity is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist (also known as a glutamate receptor modulator) and a sigma-1 receptor agonist. The bupropion component of Auvelity is an aminoketone and CYP2D6 inhibitor which serves to increase the increase and prolong the blood levels of dextromethorphan.
  • Auvelity is the first and only oral NMDA receptor antagonist approved for the treatment of MDD. It is thought to work by modulating glutamatergic neurotransmission. Abnormalities of glutamatergic neurotransmission or glutamatergic dysfunction are thought to play an important role in the development of many major psychiatric disorders, including major depressive disorder.
  • Auvelity is administered orally once daily for the first three days, then twice daily. Each extended-release tablet contains dextromethorphan hydrobromide 45 mg and bupropion hydrochloride 105 mg.
  • Warnings and precautions associated with Auvelity include increased risk of seizures, increased blood pressure and hypertension, activation of mania or hypomania, psychosis and other neuropsychiatric reactions, angle-closure glaucoma, dizziness, serotonin syndrome, and embryo-fetal toxicity.
  • Common adverse reactions include dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.


Development timeline for Auvelity

Aug 20, 2022Approval FDA Approves Auvelity (dextromethorphan and bupropion) for the Treatment of Major Depressive Disorder in Adults
May 18, 2022Axsome Therapeutics Announces Publication of Pivotal Ascend Phase 2 Trial of AXS-05 in Major Depressive Disorder in the American Journal of Psychiatry
Aug 23, 2021Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
Apr 26, 2021Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
Jun 26, 2020Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
Mar 27, 2019Axsome Therapeutics Receives FDA Breakthrough Therapy Designation For AXS-05 For The Treatment Of Major Depressive Disorder

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.