05 Abstracts at ACNP | AXSM Message Board Posts


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Msg  1662 of 1772  at  12/2/2023 5:35:32 PM  by

biobetter

The following message was updated on 12/3/2023 2:46:29 PM.

05 Abstracts at ACNP

 
MONDAY, DECEMBER 04
5
PM
Poster Session I with Reception
Mon 5 PM - 7 PM.JW, Tampa Bay Ballroom
M84 Impact of AXS-05 (dextromethorphan-Bupropion) on Depressive Symptoms, Anxiety, and Quality of Life in Patients With One Prior Treatment Failure: Results from the Evolve Long-Term, Open-Label Study
Co-Authors
Greg Mattingly, Shawn Alter, Amanda Jones, Caroline Streicher, Zachariah Thomas, Herriot Tabuteau
Key Words
AXS-05, NMDA Receptor Antagonist, Major Depressive Disorder (MDD), Quality of LIfe (QoL), Depression and Anxiety
Mon 5 PM - 7 PM.Poster.JW, Tampa Bay Ballroom
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WEDNESDAY, DECEMBER 06
5
PM
Poster Session III with Reception
Wed 5 PM - 7 PM.JW, Tampa Bay Ballroom
W79 Evaluation of AXS-05 (dextromethorphan-Bupropion) in Major Depressive Disorder Using the Interest-Activity Domain
Co-Authors
Roger S. McIntyre, Sagar V. Parikh, Rakesh Jain, Zachariah Thomas, Graham Eglit, Candace Andersson, Herriot Tabuteau
Key Words
Major Depression Disorder, N-methyl-D-aspartate, anhedonia, AXS-05
Wed 5 PM - 7 PM.Poster.JW, Tampa Bay Ballroom
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W85 Assessment of Withdrawal Symptoms After Discontinuation of AXS-05 (Dextromethorphan-Bupropion) Treatment: Results From the Gemini Trial
Co-Authors
Rakesh Jain, Candace Andersson, Caroline Streicher, Amanda Jones, Zachariah Thomas, Candace Andersson, Herriot Tabuteau
Key Words
AXS-05, Major Depressive Disorder (MDD), Withdrawal, NMDA Receptor Antagonist
Wed 5 PM - 7 PM.Poster.JW, Tampa Bay Ballroom
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Impact of AXS-05 (dextromethorphan-Bupropion) on Depressive Symptoms, Anxiety, and Quality of Life in Patients With One Prior Treatment Failure: Results from the Evolve Long-Term, Open-Label Study

Poster

Secondary Category Mood Disorders Topic Clinical

Background: In STAR*D, after failure of initial SSRI therapy, switching to an alternative monoaminergic treatment resulted in only a ~20% remission rate (Rush AJ, et al. J Clin Psychiatry. 2020;81(5):19m12949). Most approved oral antidepressants act primarily via monoaminergic mechanisms and are associated with a prolonged time to clinically meaningful response.

AXS-05 [dextromethorphan-bupropion (Auvelity® extended-release tablet)] is a novel, oral, NMDA receptor antagonist and sigma-1 receptor agonist approved by the FDA for the treatment of MDD in adults. In this study, we evaluated the impact of AXS-05 on depressive symptoms, anxiety, and quality of life in people with depression who had been treated with at least one prior treatment in their current major depressive episode (MDE).

Methods: EVOLVE was an open-label, US trial, in which patients were treated with AXS-05 (dextromethorphan HBr 45mg-bupropion HCl 105mg) twice daily for up to 15 months. Eligible patients had either rolled over following completion of a prior AXS-05 study or were directly enrolled and had a DSM-5 diagnosis of MDD, a MADRS score of ≥25, and had been treated with ≥1 prior antidepressant in the current MDE. A total of 186 patients were enrolled, consisting of 35 roll-over and 146 directly enrolled patients. Efficacy endpoints included MADRS, HAM-A, and the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF). The primary efficacy analysis was the change from baseline to Week 6 (primary timepoint) and Weeks 1 and 2 (key secondary timepoints). Here we present the results for the directly enrolled patients.

Results: Mean change in MADRS total score from a baseline of 32.2 were -9.1±7.64, -13.3±8.58, and -20.4±7.79 points at Weeks 1, 2, and 6, respectively (p<0.001 for all). Remission on the MADRS (≤10) was achieved by 5.7%, 16.2%, and 46.0% of patients at Weeks 1, 2, and 6, respectively. Remission rates increased over time and was 82% at Month 12.

Mean baseline HAM-A scores were 15.6. Reductions from baseline to Weeks 1, 2, and 6 were

3.4±5.34, 5.5±5.81, and 8.6±5.75, respectively (p<0.001 for all). Response on the HAM-A (≥50% improvement) was achieved by 18.4%, 27.9%, and 62.1% of patients at Week 1, 2, and 6, respectively. Response rates continued to improve through Month 12 (77.1%).

Mean Q-LES-Q-SF score at baseline was 42.9. Improvement from baseline to Weeks 1, 2, and 6 were 6.4±11.45, 10.4±13.14, and 18.6±13.52 (p<.001 for all). Improvements were sustained through Month 12 (24.5±16.96, p<0.001).

Long-term treatment with AXS-05 was generally well tolerated. The most commonly reported adverse events were COVID-19 infection (8.9%), nausea (8.9%), headache (7.5%), dry mouth (6.2%), insomnia (5.5%) and dizziness (5.5%).

Conclusions: In a naturalistic setting, treatment with AXS-05 improved depression symptoms, anxiety, and quality of life in patients who failed one prior antidepressant in the current MDE. These data support the long-term efficacy and safety of AXS-05 in this difficult-to-treat patient population.

 
 


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