Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting
Rapid, substantial, and durable improvement in depressive symptoms (MADRS), and functioning (SDS) with AXS-05, sustained over 12 months, (p<0.001 for all vs. baseline)
Rapid, substantial, and durable reductions in anxiety (HAM-A) with AXS-05, sustained over 12 months, (p<0.001 vs. baseline)
EVOLVE (Evaluation of NMDA Modulation for Depressive Episodes) was an open-label,
In the trial, AXS-05 rapidly, durably, and substantially improved depressive symptoms, induced remission of depression, and improved functioning in patients with at least one prior antidepressant treatment failure. The mean MADRS total score at baseline was 32.2. Mean improvements from baseline to weeks 1, 2, and 6 in MADRS total scores were -9.1 points, -13.3 points, and -20.4 points, respectively (p<0.001 for all). Improvements on the MADRS were durable through month 9 (-23.3 points, p<0.001) and month 12 (-24.5 points, p<0.001). Remission of depression (MADRS ≤10) was achieved by 16%, 32%, and 46% of patients at weeks 2, 4, and 6, respectively. Remission of depression was durable, with 65% of patients remitting at month 6 and 68% at month 12. Substantial improvements on the SDS were seen at all timepoints from a baseline value of 17.5 (p<0.001 for all). Functional remission (SDS ≤6) was achieved by 18%, 31%, and 40% and of patients at week 1, 2, and 6, respectively. Functional remission was durable, being achieved by 54% of patients at month 6 and 59% at month 12.
AXS-05 also rapidly, durably, and substantially reduced anxiety, and induced remission of anxiety in a substantial proportion of patients with MDD. The mean HAM-A score at baseline was 15.6. Mean improvements from baseline to weeks 1, 2, and 6 in HAM-A scores were -3.4 points, -5.5 points, and -8.6 points, respectively (p<0.001 for all). Improvements on the HAM-A were durable through month 6 (-10.2 points, p<0.001) and month 12 (-10.2 points, p<0.001). Remission of anxiety (HAM-A ≤ 7) was achieved by 36%, 51%, and 58% of patients at weeks 2, 4, and 6, respectively. Remission of anxiety was durable, with 75% of patients remitting at month 6 and 78% at month 12.
AXS-05 was generally well tolerated with long-term treatment and exhibited a safety profile consistent with that observed in previously reported trials.
“We are pleased to announce the results of the EVOLVE trial as late-breaking presentations at this year’s ASCP annual meeting, which further elucidate the differentiated clinical profile of AXS-05 in depression” said
Details of the poster presentations are as follows:
Title: AXS-05 (Dextromethorphan-Bupropion) Improves Depressive Symptoms and Functioning in Patients with
One Prior Treatment Failure: Results from the EVOLVE Long-Term, Open-Label Study
Presentation Number: W56
Session: Poster Session I
Title: Improvement in Anxiety Symptoms in Depressed Patients Treated with AXS-05 (Dextromethorphan-Bupropion): Results from the EVOLVE Open-label, Long-term Study
Presentation Number: W57
Session: Poster Session I
AXS-05 (dextromethorphan-bupropion) is a novel, oral, patent protected, investigational N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently approved oral therapies for major depressive disorder. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor. AXS-05 is currently covered by more than 100 issued
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Chief Operating Officer
Source: Axsome Therapeutics, Inc.