Auvelity™ (dextromethorphan HBr-buproprion HCl) extended-release tablets are now available for the treatment of adults with major depressive disorder (MDD).
Auvelity consists of dextromethorphan, a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor that serves to increase the bioavailability of dextromethorphan by competitively inhibiting cytochrome P450 2D6. The exact mechanism of action of Auvelity in the treatment of MDD is unclear.
The Food and Drug Administration (FDA) approved Auvelity in August 2022 based on efficacy and safety data from the randomized, double-blind, controlled phase 3 GEMINI (ClinicalTrials.gov: NCT04019704) and phase 2 ASCEND (ClinicalTrials.gov: NCT03595579) trials. Findings showed that Auvelity met the primary endpoint demonstrating a statistically significant improvement in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 6, compared with placebo and bupropion, respectively.
As for safety, Auvelity carries a Boxed Warning associated with the risk of suicidal thoughts and behaviors. The most common adverse reactions reported were dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.
Auvelity is supplied as dextromethorphan HBr 45mg/bupropion HCl 105mg extended-release tablets in 30-count bottles. Prior to initiating treatment, blood pressure should be assessed and monitored periodically during treatment. Patients should also be screened for a personal or family history of bipolar disorder, mania, or hypomania. It is also important to determine whether patients are receiving any other medications that contain bupropion or dextromethorphan. There are specific dosing modifications for patients with renal impairment, those on concomitant strong CYP2D6 inhibitors, and for poor CYP2D6 metabolizers.
“In clinical trials, Auvelity has demonstrated symptom improvement starting at 1 week, followed by achievement of remission in a substantial proportion of treated patients with major depressive disorder,” said Lori Englebert, Executive Vice President, Commercial and Business Development at Axsome. “We are committed to supporting access for patients to this important new therapy and have instituted a comprehensive patient support program, which includes a savings card for eligible patients and educational resources to facilitate discussions between patients and their physicians.”
Axsome Therapeutics announces availability of Auvelity™, the first and only oral NMDA receptor antagonist for the treatment of major depressive disorder in adults. News release. Axsome Therapeutics. Accessed October 20, 2022. https://www.globenewswire.com/news-release/2022/10/20/2538159/33090/en/Axsome-Therapeutics-Announces-Availability-of-AUVELITY-the-First-and-Only-Oral-NMDA-Receptor-Antagonist-for-the-Treatment-of-Major-Depressive-Disorder-in-Adults.html
This article originally appeared on MPR