Prior research has identified several risk factors for inadequate 2-hour pain freedom (PF) following acute migraine treatment including high body mass index (BMI), allodynia, morning migraine, and history of depression.  Treatments that improve PF rates in individuals with these risk factors are urgently needed.

AXS-07 has demonstrated efficacy in two clinical trials: MOMENTUM and INTERCEPT.  MOMENTUM (N=1594) enrolled only patients with a history of inadequate response to prior acute migraine treatments.  Subjects were randomized either to AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), rizatriptan (10 mg), MoSEIC meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. 

In INTERCEPT (N=352) patients were randomized (1:1) to receive a single dose of AXS-07 or placebo and instructed to self-administer treatment at the earliest sign of migraine pain, while the pain was mild.

Here we report a pooled analysis of 2-hour PF rates with AXS-07 compared to placebo in patients with the following risk factors for inadequate response: higher BMI, allodynia, morning migraine, and history of depression. 

Pooled 2-hour PF rates, stratified by risk factors for inadequate response for AXS-07 (N=560) and placebo (N=344), respectively, were: 19.1% vs. 9.9% (p=0.004) for BMI ≥ to the median BMI (28.8 kg/m2), 23.3% vs. 11.0% (p<0.001) for presence of allodynia, 23.5% vs. 10.5% (p<0.001) for morning migraine, and 23.1% vs. 5.9% (p=0.004) for history of depression.

The most common adverse events reported in the AXS-07 group were nausea (2.4%), somnolence (2.1%), and dizziness (1.9%).

Among patients with documented risk factors for non-response to acute migraine medication, treatment with AXS-07 resulted in a statistically significant greater percentage of patients achieving 2-hour pain freedom compared to placebo.