Treatment with AXS-07, an investigational therapy being developed by Axsome Therapeutics, substantially reduced migraine pain and significantly prevented the progression of migraine pain intensity, according to results of the phase 3 INTERCEPT trial. 

The oral, multi-mechanistic agent, which consists of meloxicam, a nonsteroidal anti-inflammatory drug, and rizatriptan, a 5-HT1B/1D agonist, is believed to decrease neuroinflammation, pain signal transmission, and central sensitization through calcitonin gene-related peptide inhibition. 

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 end points of the trial included the proportion of patients free from headache pain 2 hours after dosing and the proportion of patients who did not experience their most bothersome migraine-associated symptom 2 hours after dosing. 

Results showed that compared with 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 most bothersome symptom (43.9% vs 26.7%, P =.003) 2 hours after dosing. Statistical significance for migraine pain freedom was achieved at 90 minutes with AXS-07 (P =.003) and at every time thereafter.

Findings of the study also revealed that patients who received AXS-07 were more likely to experience sustained pain freedom compared with placebo patients from 2 to 24 hours after dosing (22.7% vs 12.6%, respectively; P =.030) as well as from 2 to 48 hours after dosing (20.5% vs 9.6%, respectively; P =.013). 

Moreover, the data showed that 73.5% of AXS-07 patients did not experience progression of migraine pain beyond mild intensity 2 to 24 hours after dosing compared with 47.4% of placebo patients (P <.001). 

The analysis also revealed that fewer AXS-07 patients utilized rescue medication over 24 hours compared with placebo patients (15.3% vs 42.2%, respectively; P <.001). 

As for functional improvement, results showed that at 24 hours, 73.5% of AXS-07-treated patients achieved the ability to perform normal activities compared with 47.4% of placebo patients (P <.001). 

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“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 2 positive well-controlled trials,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “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 Company plans to submit a New Drug Application for AXS-07 to the Food and Drug Administration in the fourth quarter of 2020.

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