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Findings

What does this study add?

  • Compared with placebo, a statistically significant greater proportion of patients were pain free and free of MBS at 2 hours with AXS-07 treatment.
  • A statistically significant greater percentage of AXS-07 patients achieved sustained pain freedom from 2–24 hours after dosing compared to rizatriptan and MoSEIC™ meloxicam.
  • Efficacy benefits of AXS-07 translated into statistically significantly better patient global assessment of response, return to normal functioning and reduced rescue medication use.
  • AXS-07 was well tolerated, with the most common adverse events being nausea, dizziness and somnolence, none of which occurred at a higher rate than placebo.