Abstract Details

AXS-07 (MoSEIC meloxicam-rizatriptan) is a novel, oral, rapidly-absorbed, multimechanistic investigational medicine.  Meloxicam is a new molecular entity for migraine enabled by MoSEIC technology, resulting in rapid absorption while maintaining a long half-life.

The MOVEMENT trial aimed to evaluate the long-term efficacy and safety of AXS-07 for the acute treatment of migraine.

MOVEMENT was a Phase 3, long-term, open-label study that enrolled patients who had completed the previous pivotal trials of AXS-07: MOMENTUM and INTERCEPT. Patients could treat up to 10 migraine attacks per month over the up to 12-month period, with 1 dose of AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan) for each migraine.

706 patients were enrolled. AXS-07 rapidly and substantially relieved pain and most bothersome symptoms (MBS). Pain relief (PR) was achieved by 39% and 68% of patients within 1 and 2hrs post dose, respectively. Pain freedom (PF) and absence of MBS was achieved by 38% and 47% of patients, respectively, 2hrs post dose. PR with AXS-07 was durable. Sustained PR from 2–24 and 2–48hrs was achieved by 60% and 59% of patients, respectively. Sustained PF from 2–24 and 2–48hrs was achieved by 33% and 32% of patients, respectively. 85% of patients remained free of rescue medication use through 24hrs, and 83% through 48hrs, after a single dose.  AXS-07 was generally safe and well tolerated. The most commonly reported adverse events (≥ 3%) over the 12-month treatment period were nausea, dizziness, and vomiting.

AXS-07 rapidly, substantially, and durably relieved migraine pain and MBS.