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Axsome Therapeutics Inc (AXSM)

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  • May 18, 2022, 11:05 UTC

(90% Positive) Axsome Therapeutics, Inc. (AXSM) Announces Enrollment Update for Institute Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot Oct. 1, 2025, 8:51 p.m.

    📋 Axsome Therapeutics, Inc. (AXSM) - Clinical Trial Update

    Filing Date: 2022-05-18

    Accepted: 2022-05-18 07:05:55

    Event Type: Clinical Trial Update

    Event Details:

    Axsome Therapeutics Inc (AXSM) Announces Clinical Trial Update Axsome Therapeutics Inc (AXSM) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: Institute, results
    • Diseases/Conditions: Psychiatric Research
    • Clinical Stage: Phase 2 Trial, clinical trial
    • Collaboration: MDD
      • targeting glutamate and sigma-1 receptors, and to its robust antidepressant efficacy demonstrated in this study, AXS-05 has the potential to become an important and very useful new treatment for patients with major depressive disorder.” “We are very pleased with the publication of the ASCEND trial results in The American Journal of Psychiatry, the most widely read psychiatric journal in the world1,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “ASCEND is one of the pivotal efficacy trials that forms the basis of our NDA for AXS-05 in depression, which is currently under review by the FDA. Axsome is positioned to move expeditiously to make this product available to patients as quickly as possible, should it be approved.” The ASCEND trial assessed the efficacy and safety of AXS-05 versus the active comparator bupropion in patients with MDD. A total of 80 patients with a diagnosis of moderate to severe MDD, confirmed by an independent clinical assessor, were randomized to receive AXS-05 (45 mg dextromethorphan/105 mg bupropion tablet) (n=43), or bupropion (105 mg tablet) (n=37), once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was overall treatment effect on the Montgomery-Åsberg Depression Rating Scale (MADRS) score (average of the change from baseline for weeks 1–6). In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in depressive symptoms and induction of remission compared with bupropion. The mean change from baseline in MADRS score over weeks 1–6 was significantly greater with AXS-05 than with bupropion (-13.7 points vs. -8.8 points; least-squares mean difference=-4.9; p

    💼 Business Developments:

    • Partnership
    • Acquisition
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Axsome Therapeutics Inc
    • CIK: 0001579428
    • Ticker Symbol: AXSM
    • Period End Date: 2022-05-18
    • Document Type: 8-K

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