Through both 24 and 48 hours after single-dose treatment, 85% and 83% of patients, respectively, remained free of the need for rescue medication.
AXS-07 (Axsome Therapeutics), an investigational agent currently under FDA review, continued to show rapid and sustained relief of migraine pain and the most bothersome symptoms (MBS) in a new 12-month analysis.1
The oral and dual-mechanism therapy was reportedly safe and well-tolerated, with minimal adverse events (AEs) during the study period. The data, stemming from the phase 3 MOVEMENT trial (NCT04068051), were presented by lead investigator Amanda Jones, PharmD, senior vice president, Clinical Development, Axsome Therapeutics, and colleagues, at the 2022 American Academy of Neurology (AAN) annual meeting, April 2-7, in Seattle, Washington.
AXS-07 consists of a combination of the company’s molecular solubility enhanced inclusion complex (MoSEIC) 20-mg meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug, and 10-mg rizatriptan, a 5-HT1B/1D agonist. In September 2021, the FDA accepted the new drug application (NDA) of AXS-07 for the acute treatment of migraine and scheduled a Prescription Drug User Fee Act date of April 30, 2022.
The NDA was supported by results from 2 pivotal phase 3 randomized controlled trials of AXS-07, the MOMENTUM trial (NCT03896009) and INTERCEPT trial (NCT04163185). MOVEMENT, a long-term, open-label study, included 706 patients with at least 10 migraine attacks per month who had completed one of those previous trials.
At the conclusion of the analysis, pain relief (PR) was achieved by 39% and 68% of patients within 1- and 2-hours post-dose, respectively. At 2 hours post-dose, 38% of patients achieved pain freedom (PF) and 47% were free from their MBS. From 2 to 24 hours and 2 to 48 hours, 60% and 59% of patients, respectively, showed sustained PR. Sustained PF during those same time points were achieved by 33% and 32% of patients, respectively.
In total, 85% of patients did not need rescue medication through the first 24 hours after single-dose treatment. Results remained fairly unchanged at 48 hours, with 83% of patients remaining free from rescue medication. Over the 12-month treatment period, the most commonly reported adverse events (AEs) were nausea, dizziness, and vomiting.
Data from the MOMENTUM trial were originally announced in January 2020.2 The trial included 1594 patients randomized in a 2:2:2:1 ratio to AXS-07, 10-mg rizatriptan, MoSEIC 20-mg meloxicam, or placebo, to treat a single migraine attack of moderate or severe intensity. AXS-07 met the coprimary end points with statistical significance, first showing a greater percentage of patients achieving pain freedom (19.9%) compared with placebo (6.7%; P <.001). Second, the absence of the most bothersome symptom (36.9%) compared with placebo (24.4%) was significant (P = .002). Both were assessed 2 hours after dosing.
As for its secondary end point, compared to rizatriptan, MoSEIC meloxicam, and placebo, AXS-07 showed significant numbers of patients achieving pain-freedom (16.1%, 11.2%, 8.8%, and 5.3%, respectively; P = .038, P = .001, and P <.001, respectively versus AXS-07).
Months later, topline data from INTERCEPT were announced. In all, the therapy met its co-primary end points of PR and freedom of MBS, as well as showed substantial and significant elimination of migraine pain and prevented progression of migraine pain intensity. Investigators observed a statistically significantly greater percentage of patients achieving PR compared to placebo (32.6% versus 16.3%, respectively; P = .002), as well as freedom from the MBS (43.9% versus 26.7%, respectively; P = .003), 2 hours after dosing.3
In addition to meeting the primary end points, the agent showed efficacy in preventing progression of migraine pain beyond mild intensity while significantly reducing the use of rescue medication. Between 2 and 24 hours after dosing, freedom of pain progression occurred in 73.5% of AXS-07 patients compared with 47.4% of placebo patients (P <.001).