Atogepant Shows Superiority Over Topiramate for Migraine Prevention
Topline results from a phase 3 trial showed 64.1% of patients on atogepant achieved a 50% or greater reduction in mean monthly migraine days during months 4 to 6.
Positive topline results have been announced from a phase 3 trial evaluating the tolerability, safety, and efficacy of atogepant (Qulipta) compared to topiramate for the prevention of migraine in adult patients, AbbVie announced in a release.1 The company said it plans to present full data from the study at an upcoming medical conference.
Atogepant Shows Superiority Over Topiramate for Migraine Prevention / Damir Khabirov - stock.adobe.com
Results from the TEMPLE (NCT05748483) trial showed that atogepant met its primary study endpoint of treatment discontinuation due to adverse events. The therapy also met all 6 key secondary study endpoints, including the percentage of patients achieving 50% or greater improvement in mean monthly migraine days and change from baseline in mean monthly migraine days.
"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," Jaclyn Duvall, MD, neurologist and founder of Headache Specialists of Oklahoma, said in a release.1 "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention."
TEMPLE is a multicenter, randomized, double-blind, active-controlled phase 3 clinical trial evaluating the tolerability, safety, and efficacy of atogepant compared to topiramate in adult patients with a history of 4 or more migraine days per month. The study cohort included 545 patients with episodic or chronic migraine across 73 sites in Europe, Israel, and Canada.
The study was conducted in 2 phases. In the initial 24-week double-blind period, patients randomly received either 60 mg atogepant once daily or the highest tolerated dose—50 to 100 mg a day—of topiramate. This phase included a 6-week dose-titration period followed by 18 weeks of maintenance treatment. Eligible patients then entered a 52-week open-label extension study.
The study found that 12.1% of patients treated with atogepant discontinued due to adverse events over the 24-week period, compared to 29.6% of patients who received topiramate. Additionally, 64.1% of patients who received atogepant achieved a 50% or greater reduction in mean monthly migraine days during months 4 to 6, compared to 39.3% of patients who received topiramate.
"These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in a release.1 "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease."
Atogepant is a once-daily oral medication designed to prevent migraines in adult patients. It works by blocking the calcitonin gene-related peptide (CGRP) receptor, a key target in migraine biology. CGRP and its receptors are found in areas of the nervous system involved in migraine development, and studies have shown that CGRP levels rise during migraine attacks.
READ MORE: Headache and Migraine Resource Center
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