Phase 3 Trial Results Found New Meloxicam/Rizatriptan Drug Reduces Migraine Pain

April 24, 2020

Results of the phase 3 INTERCEPT trial showed that patients who received treatment with novel AXS-07 had substantially reduced migraine pain.

Results of the phase 3 INTERCEPT trial showed that treatment with the investigational therapy AXS-07 substantially reduced migraine pain and significantly prevented the progression of migraine pain intensity.

AXS-07 is an oral, multi-mechanistic agent that consists of the nonsteroidal anti-inflammatory drug meloxicam and rizatriptan, a 5-HT1B/1D agonist. It is being developed by Axsome Therapeutics and is thought to decrease neuroinflammation, pain signal transmission, and central sensitization through calcitonin gene-related peptide inhibition.

“With INTERCEPT and the previously completed MOMENTUM Phase 3 trial in patients with a history of inadequate response to prior acute treatments, AXS-07 has now been evaluated in two positive well-controlled trials,” said Herriot Tabuteau, MD, chief executive officer of Axsome Therapeutics, in a company press release. “These trials demonstrate the efficacy of AXS-07 against potent active and placebo comparators, across a spectrum of migraine attack settings, regardless of the timing of migraine treatment, disease severity, or baseline pain intensity.”

The randomized, double-blind, placebo-controlled study included 302 patients who received either a single dose of AXS-07 or placebo at the first sign of migraine pain, when the pain intensity was considered mild.

The co-primary endpoints in the study were the proportion of patients free from headache pain 2 hours after dosing and the proportion of patients who did not experience their most troublesome migraine-associated symptoms 2 hours after dosing.

The results showed that, compared to placebo, a statistically significantly greater percentage of patients treated with AXS-07 achieved pain freedom (32.6% vs 16.3%, P=.002) and freedom from the most bothersome symptom (43.9% vs 26.7%, P=.003) 2 hours after dosing.

Statistical significance for freedom from migraine pain was achieved at 90 minutes with AXS-07 (P=.003) and at every time thereafter.

The results also suggest that patients treated with AXS-07 were more likely to experience sustained pain freedom vs patients who received placebo from 2-24 hours after dosing (22.7% vs 12.6%, respectively; P=.03) and from 2-48 hours after dosing (20.5% vs 9.6%, respectively; P=0.13)

Other key findings include:

·73.5% of AXS-07 patients did not experience progression of migraine pain beyond mild intensity 2-24 hours after dosing vs 47.4% of placebo patients (P<.001)

·Fewer AXS-07 patients utilized rescue medication over 24 hours vs placebo patients (15.3% vs 42.2%, respectively; P<.001)

·73.5% of AXS-07 patients achieved the ability to perform normal activities at 24 hours vs 47.7% of placebo patients (P<.001).

Axsome Therapeutics plans to submit a new drug application for AXS-07 to the US Food and Drug Administration in the fourth quarter of 2020. 

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