AXS 07 eliminated migraine pain, and substantially and significantly prevented progression of migraine pain in the INTERCEPT phase III trial in the early treatment of migraine.- Axsome Therapeutics

Axsome Therapeutics, Inc. announced that AXS 07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain intensity in the INTERCEPT Phase III trial of AXS 07 in the early treatment of migraine.

In the trial, AXS 07 met the co-primary endpoints of freedom from migraine pain and freedom from most bothersome symptoms as compared to placebo. AXS 07 is Axsome’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine. INTERCEPT was a randomized, double-blind, placebo-controlled trial in which a total of 302 patients were randomized in a 1:1 ratio to treat a single migraine attack with a single dose of AXS 07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), or placebo, at the earliest sign of migraine pain, while the pain intensity was mild.

AXS 07 met both of the two co-primary endpoints by demonstrating a statistically significantly greater percentage of patients as compared to placebo achieving pain freedom (32.6% versus 16.3%, p=0.002) and freedom from most bothersome symptom (43.9% versus 26.7%, p=0.003), 2 hours after dosing. AXS 07 durably relieved migraine pain with a statistically significantly greater percentage of patients as compared to placebo achieving sustained pain freedom from 2 to 24 hours after dosing (22.7% versus 12.6%, p=0.030), and from 2 to 48 hours after dosing (20.5% versus 9.6%, p=0.013). AXS 07 rapidly eliminated migraine symptoms, with numerical separation from placebo as early as 30 minutes for migraine pain freedom and most bothersome symptom freedom, achieving statistical significance for migraine pain at 90 minutes (p=0.003) and at every timepoint thereafter.

A single dose of AXS 07 significantly prevented progression of migraine pain beyond mild intensity while significantly reducing the use of rescue medication. Freedom from pain progression from 2 to 24 hours after dosing was achieved by 73.5% of AXS 07 patients versus 47.4% of placebo patients (p<0.001). The effect on pain progression translated to a significant reduction in the use of rescue medication, with only 15.3% of AXS 07 patients requiring rescue medication through 24 hours after dosing, versus 42.2% of placebo patients (p<0.001).

AXS 07 substantially and significantly reduced functional disability, and demonstrated overall disease improvement. AXS 07 treatment resulted in 73.5% of patients able to perform normal activities at 24 hours compared to 47.4% of placebo patients (p<0.001). On the Patient Global Impression of Change (PGI-C) scale, 52.4% of AXS 07 patients were very much or much improved compared to 27.7% of placebo patients (p<0.001).

AXS 07 was generally safe and well tolerated in the trial. The most commonly reported adverse events with AXS07 were somnolence, dizziness, and paresthesia, all of which occurred at a rate of less than five percent. There were no serious adverse events in the trial.