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
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