Investigational agent works well for migraine in pooled analysis

Treatment with the investigational agent AXS-07 significantly alleviates pain and most bothersome symptoms (MBS) in patients with migraine, according to results of a pooled analysis of the phase III MOMENTUM and INTERCEPT trials presented at AAN 2024.

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational agent that consists of MoSEIC™ meloxicam and rizatriptan for acute migraine treatment.

Previous studies have shown that AXS-07 improved clinical outcomes (MOMENTUM trial) and resulted in rapid, substantial, and sustained pain relief as an early treatment for migraine (INTERCEPT trial). [Neurology 2020;95:e439-e445; Headache 2021;61(Suppl 1):1-178(IOR-04)]

To further evaluate the efficacy and safety of AXS-07, the researchers conducted a pooled analysis of the MOMENTUM (n=428) and INTERCEPT (n=132) trials involving patients with migraine (mean age 41.3 years, 82 percent female).

The participants were randomly assigned to receive either a single dose of AXS-07 (MoSEIC™ meloxicam 20 mg and rizatriptan 10 mg; n=560) or placebo (n=344) for the treatment of a single migraine attack of moderate or severe pain intensity (MOMENTUM cohort) and the earliest onset of migraine (INTERCEPT cohort).

At 2 hours after dosing, significantly more patients treated with AXS-07 were free from pain (23 percent vs 11 percent; p<0.001) and experienced freedom from MBS, such as nausea, photophobia, or phonophobia (39 percent vs 25 percent; p<0.001). [AAN 2024, abstract P7.002]

Moreover, patients in the AXS-07 group were significantly more likely to experience sustained freedom from pain for 24 hours (18 percent vs 8 percent; p<0.001) and 48 hours (16 percent vs 7 percent; p<0.001) than those in the placebo group.

Of note, more AXS-07 recipients were able to return to their normal function as early as 1 hour after dosing than the placebo recipients (14 percent vs 9 percent; p=0.012), which was maintained up to 24 hours (66 percent vs 47 percent; p<0.001).

The rate of rescue medication use within 24 hours after the dose was also significantly lower in the AXS-07 group than the placebo group (21 percent vs 43 percent; p<0.001).

In terms of safety, treatment-emergent adverse events (TEAEs) occurred in 12.7 percent of patients on AXS-07 and 6.6 percent of patients on placebo.

Nausea (2.4 percent vs 2.5 percent), somnolence (2.1 percent vs 1.1 percent), and dizziness (1.9 percent vs 1.1 percent) were the most frequently reported TEAEs in the AXS-07 vs the placebo group.

“AXS-07 was generally safe and well tolerated,” noted the researchers.

“Overall, pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favourable tolerability profile,” they concluded.