AbbVie has announced results from its Phase 3 TEMPLE study, which evaluated the tolerability, safety, and efficacy of atogepant compared to topiramate for migraine prevention in adults. The study found that atogepant led to fewer treatment discontinuations due to adverse events than topiramate. Additionally, all six secondary endpoints showed statistical significance for superiority over topiramate.
Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer at AbbVie stated, "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."
The trial included 545 participants across Europe, Israel, and Canada. Participants were randomized to receive either atogepant or the highest tolerated dose of topiramate during a 24-week double-blind treatment period. Following this phase, eligible participants entered a 52-week open-label period where they received atogepant.
Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma remarked on the findings: "Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options."
Atogepant is marketed under the names AQUIPTA in the EU and QULIPTA in several other regions. It is approved in 60 countries as a once-daily oral CGRP receptor antagonist.
Full results from the TEMPLE study will be presented at an upcoming medical meeting.