Clinical Data
AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p<0.001). AXS-07 substantially and significantly reduced relapse of migraine pain as compared to rizatriptan, with 45.2% of rizatriptan-treated patients experiencing relapse compared to 21.2% of AXS-07 patients over 48 hours after dosing (p=0.001).The results on time to migraine pain relief and relapse are consistent with the superiority of AXS-07 over rizatriptan on several other efficacy measures, as previously reported, including rescue medication use (p<0.001), sustained pain relief over 24 hours (p=0.006) and 48 hours (p=0.003), sustained pain freedom over 24 hours (p=0.038) and 48 hours (p=0.003), Patient Global Impression of Change (p=0.022) at 2 hours, and return to normal functioning at 24 hours (p=0.027). Also as previously reported, AXS-07 met both co-primary endpoints of the trial by demonstrating a greater percentage of patients achieving pain freedom (p<0.001) and absence of most bothersome symptom (p=0.002), 2 hours after dosing, as compared to placebo.