Combined Efficacy and Safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) in Two Phase 3 Clinical Trials
Stewart Tepper1, Richard Lipton2, Angad Chhabra3, Caroline Streicher3, Gregory Parks3, Herriot Tabuteau3
1Geisel School of Medicine At Dartmouth, 2Albert Einstein College of Medicine, 3Axsome Therapeutics
Objective:
To characterize the efficacy and safety profiles of AXS-07 in the acute treatment of migraine headache by pooling two phase 3 clinical studies.
Background:
AXS-07 is a rapidly absorbed, oral combination product consisting of MoSEIC™ meloxicam (20mg), a COX-2 preferential NSAID, and rizatriptan (10 mg), a 5 HT1B/1D agonist. The efficacy of AXS-07 was demonstrated in two clinical trials: MOMEMTUM, a 4-arm factorial study, and INTERCEPT, a 2-arm placebo-controlled trial.
Design/Methods:
MOMENTUM and INTERCEPT enrolled patients with an inadequate response to prior acute treatment into blinded, placebo-controlled studies. In MOMENTUM, participants were randomized to AXS-07, placebo, meloxicam (20mg), or rizatriptan (10mg) to treat a single migraine attack of moderate or severe intensity. In INTERCEPT, participants took AXS-07 or placebo at the earliest onset of migraine pain. Primary endpoints were pain freedom at 2 hours and freedom from most bothersome symptom (MBS). Results from the two studies compared to placebo were pooled for the present analysis.
Results:
In the pooled analysis, AXS-07 demonstrated greater headache pain freedom (23% vs 11%, p<0.001) and absence of MBS (39% vs 25%, p<0.001) at 2 hours compared to placebo. Participants taking AXS-07 demonstrated improved sustained pain freedom between 2 and 24 hours (18% vs 8%, p<0.001) and 48 hours (16% vs 7%, p<0.001) and had reduced rescue medication use through 24 hours (43% vs 21%, p<0.001) compared to placebo. More participants treated with AXS-07 returned to normal functioning in comparison with placebo starting at 1-hour post-dose. Treatment-emergent adverse events (TEAEs) were experienced by 12.7% of participants taking AXS-07 compared to 6.6% on placebo. The most common TEAEs with AXS-07 were nausea, somnolence, and dizziness.
Conclusions:
Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile.