AXS-07 Shines at AAN 2024: A New Era in Migraine Treatment

• AXS-07, a cutting-edge oral solution, blends MoSEIC meloxicam and rizatriptan, offering rapid absorption. It ingeniously inhibits CGRP release, counteracting vasodilation, and curbing neuroinflammation and pain transmission for enhanced relief.
• AXS-07 demonstrates superior efficacy in swiftly alleviating migraine symptoms with remarkable tolerability, significantly reducing pain and most bothersome symptoms compared to placebo.

At the American Academy of Neurology conference 2024, Axsome Therapeutics unveiled a compelling poster elucidating the combined efficacy and safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) through a thorough synthesis of two pivotal Phase III clinical trials, MOMENTUM (NCT03896009) and INTERCEPT (NCT04163185). In the dynamic trials of MOMENTUM and INTERCEPT, individuals with suboptimal responses to previous acute therapies were systematically enrolled into rigorous, placebo-controlled investigations. MOMENTUM’s randomized regimen encompassed AXS-07, placebo, meloxicam (20mg), or rizatriptan (10mg) for addressing singular migraine episodes of moderate or severe intensity. Conversely, INTERCEPT participants promptly administered AXS-07 or placebo upon initial onset of migraine discomfort. Notably, pivotal endpoints, including 2-hour pain liberation and relief from most bothersome symptoms (MBS), were meticulously scrutinized. The collective findings from both trials, set against placebo, were combined for the pooled analysis.

The pooled analysis showcased AXS-07’s profound efficacy in combating migraine symptoms, as participants experienced significantly higher rates of headache pain freedom (23% vs. 11%) and absence of most bothersome symptoms (39% vs. 25%) at 2 hours, compared to placebo, with p-values indicating statistical significance (p < 0.001). Notably, AXS-07 users sustained pain freedom from 2 to 48 hours, demonstrating remarkable improvements (18% vs. 8% at 2-24 hours; 16% vs. 7% at 48 hours). Moreover, AXS-07 recipients exhibited reduced rescue medication usage through 24 hours (43% vs. 21%, p <0.001), enhancing overall treatment outcomes. Despite a slightly higher incidence of treatment-emergent adverse events (12.7% vs. 6.6% on placebo), AXS-07 demonstrated superior efficacy with manageable tolerability.

Conclusion: AXS-07 emerges as a groundbreaking solution for migraine management, swiftly alleviating symptoms with remarkable efficacy and tolerability. Its multifaceted mechanisms target various physiological processes underlying migraine attacks, as evidenced by achieving co-primary endpoints in both MOMENTUM and INTERCEPT trials. Notably, AXS-07’s rapid pain relief in MOMENTUM and substantial reduction in functional disability in INTERCEPT signify its potential to revolutionize migraine treatment, offering hope for improved patient outcomes.