AXS-07 showed statistical significance for migraine pain freedom at 90 minutes, and at every time point after.
Stewart Tepper, MD
This article, "AXS-07 Meets Primary End Points, Halts Migraine Pain Progression," was originally published in NeurologyLive.
A new drug may soon help eliminate migraine pain and prevent the progression of migraine pain intensity.
In the INTERCEPT phase 3 trial, AXS-07 met all co-primary end points and showed efficacy in preventing the progression of migraine pain beyond mild intensity while significantly reducing the use of rescue medication.
AXS-07’s formulation consists of both MoSEIC meloxicam and rizatriptan and it is administered in tablet form to provide an enhanced rate of absorption of meloxicam.
INTERCEPT was a double-blind, placebo-controlled trial that included 302 patients randomized 1:1 to treat a single migraine attack with a single dose of AXS-07 (20 mg meloxicam/10 mg rizatriptan), or placebo, at the earliest sign of migraine pain, while the pain intensity was mild.
The investigators sought primary outcome measures observed included percentage of patients reporting headache pain freedom at 2 hours and percentage of patients with absence of most bothersome symptoms.
They also sought co-primary end points of pain freedom and freedom from the most bothersome symptom.
There were a statistically significantly greater percentage of patients achieving pain freedom compared to placebo (32.6% versus 16.3%, respectively; P = .002), as well as freedom from the most bothersome symptom (43.9% versus 26.7%, respectively; P = .003), 2 hours after dosing.
Between 2-24 hours after dosing, freedom of pain progression occurred in 73.5% of AXS-07 patients compared with 47.4% of placebo patients (P <.001).
The drug showed significant results on both co-primary end points but was also numerically superior to placebo in a multitude of other end points.
Pain freedom and most bothersome symptom freedom was achieved as early as 30 minutes in patients who received AXS-07. Additionally, the drug achieved statistical significance for migraine pain freedom at 90 minutes (P = .003) and at every time point after.
Sustained pain freedom from 2-24 hours after dosing was experienced by 22.7% and 12.6% of patients treated with AXS-07 and placebo, respectively (P = .030). Similar sustained pain freedom from 2-48 hours after dosing was seen in both AXS-07 and placebo patients as well (20.5% vs 9.6%; P = .013).
While the drug prevented progression of migraine pain intensity, rescue medication was used by 15.3% of AXS-07 patients compared to 42.2% of placebo patients over 24 hours (P <.001).
Researchers observed functional and global improvement as well, noting that 52.4% of AXS-07 patients were very much or much improved compared to 27.7% of placebo patients (P <.001) on the Patient Global Impression of Change (PGI-C) scale.
The drug was generally safe and well tolerated with no reports of serious adverse events (AEs) throughout the trial. Somnolence, dizziness and paresthesia, all of which occurred in less than 5%, were among the most commonly reported adverse events.
“These results, coupled with previous clinical data showing superiority of AXS-07 over an active comparator, provide clinical evidence that this synergistic, multi-mechanistic approach and the rapid absorption of AXS-07 may translate to important benefits for a wide range of patients,” Stewart Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth University, said in a statement. “As clinicians continue to seek options for their patients with improved efficacy over currently available therapies, AXS-07 may offer an important new treatment for this disabling condition.”