Trending Clinical Topic: Migraine

Ryan Syrek


July 02, 2021

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Studies presented at the recent American Headache Society (AHS) Annual Meeting resulted in this week's top trending clinical topic. Findings from the phase 3 INTERCEPT trial demonstrated that an orally administered, novel nonsteroidal anti-inflammatory drug (NSAID)/triptan medication is effective in treating migraine pain. AXS-07 is similar to a previous formulation combining naproxen sodium and sumatriptan; in both combination medications, one drug addresses pain mechanisms that the other does not. The study included patients aged 18-65 years, 85% of whom were women. AXS-07 demonstrated clear efficacy in the trial's two primary endpoints: pain freedom and freedom from the most bothersome symptom 2 hours after dosing (see Infographic below). AXS-07 also significantly reduced functional disability, with 74% of patients who received the drug reporting no disability at 24 hours, compared with 47% of patients who received placebo.

A separate study presented at the AHS meeting found that the monoclonal antibody eptinezumab provided freedom from migraine headache pain quickly after intravenous administration. RELIEF, a randomized controlled trial, showed that those who received the drug were more likely to be free of pain (9.7%) and their most bothersome symptom (33.2%) at 1 hour, compared with those who received placebo (4.1% and 22.1%, respectively). Thirty minutes after treatment, more than one third of the patients who received eptinezumab were also free of nausea, compared with about one quarter of those who received placebo.

In terms of studies on prevention, other research presented at AHS showed that the combination of onabotulinumtoxinA (Botox) and anti–calcitonin gene-related peptide (CGRP) antibodies is effective in reducing headache days per month. The new findings suggest that the combination resulted in a 4-day reduction, compared with a 2-day benefit found in a separate study of treatment with just erenumab, the most commonly used anti-CGRP antibody, in patients who did not respond to at least two oral preventives. Also important: Patients who are receiving onabotulinumtoxinA and/or CGRP pathway monoclonal antibodies can safely receive any of the COVID-19 vaccines without concerns, according to a separate presentation.

In nonmedication treatment news, results of a randomized, sham-controlled trial found that a noninvasive, self-administered neurostimulation device recently approved by the US Food and Drug Administration is safe, tolerable, and offers "highly effective" pain relief in acute migraine. The study found that 46% of patients with acute migraine achieved complete freedom from pain 2 hours after treatment with combined occipital and trigeminal nerve stimulation (COT-NS) vs 11.8% of those assigned to sham stimulation.

These treatment findings are probably a relief to those who experience migraine headaches, as data presented at AHS also showed that nearly half of those affected hesitate to seek appropriate care. A survey of nearly 18,000 people with migraine found that 46% were reluctant to consult a doctor. Separate survey research also found that, among those who actually seek medical care for migraine, 35% of those who were eligible for preventive therapy were not offered that option. Less than 10% surveyed were currently taking preventive medication.

Given the often debilitating symptoms associated with migraine, it is no wonder that so many presentations at AHS focused on the condition or that it became this week's top trending clinical topic.

Read more clinical information on migraine.


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