Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder
AXS-05 rapidly and significantly improved anhedonic symptoms, measured by the MADRS anhedonia subscale, starting 1 week after treatment
Data being presented at the
“Anhedonia is a disabling, common, and persistent feature of depression that substantially impairs patient functioning,” said
Anhedonia is an impaired capacity to experience or anticipate pleasure. It is present in up to 75% of individuals with MDD1 and is ranked among the most bothersome symptoms of depression. Anhedonia is associated with suboptimal antidepressant treatment response and poor functional outcomes2,3.
The GEMINI trial assessed the efficacy and safety of AXS-05 versus placebo in patients with MDD. A total of 327 patients with a confirmed diagnosis of moderate to severe MDD were randomized to receive AXS-05 (45 mg dextromethorphan/105 mg bupropion tablet) (n=163), or placebo (n=164), once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was the treatment effect on the
In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in symptoms of anhedonia compared with placebo. The change from baseline to week 6 on the MADRS anhedonia subscale was significantly greater with AXS-05 than with placebo (-9.70 points vs. -7.22 points; p=0.001). The improvement was rapid with the change on the MADRS anhedonia subscale from baseline to week 1, the first timepoint assessed, being significantly greater with AXS-05 than with placebo (-4.44 points vs. -2.69 points; p<0.001). Response, defined as at least a 50% improvement on the anhedonia subscale, was achieved by a statistically significantly greater proportion of patients treated with AXS-05 than with placebo at week 1 (p<0.001) and at every timepoint thereafter. At week 6, response on the anhedonia subscale was achieved by 54% of patients treated with AXS-05 compared to 36% of patients treated with placebo (p=0.002).
“We are pleased to present these new data on AXS-05 at the 2022 annual meeting of the
Details of the poster presentation are as follows:
Title: Impact of AXS-05, an Oral NMDA Receptor Antagonist, on Anhedonic Symptoms in Major Depressive Disorder
Presentation Number: Th22
Session: Poster Session II
Date:
Time:
Location:
About AXS-05
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
About
Forward Looking Statements
Certain matters discussed in this press release are "forward-looking statements". We may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our newly acquired Sunosi product; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application ("NDA") for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Axsome Contact:
Chief Operating Officer
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
References
- Franken IH, et al. J Affect Disord 2007;99:83 9.
- Baune BT, et al. Neuropsychiatr Dis Treat 2021;17:2995 3006.
- Wardenaar KJ, et al. J. Affect. Disord 2012; 136:1198 1203.
Source: Axsome Therapeutics, Inc.