AbbVie presents new data showing Atogepant (QULIPTA / AQUIPTA) success

AbbVie recently shared new data displaying the superiority of Atogepant (QULIPTA® / AQUIPTA®) over topiramate in a Phase 3 head-to-head study focused on migraine prevention. This study, known as TEMPLE, was designed to assess the effectiveness, safety, and tolerability of Atogepant relative to topiramate in adult patients experiencing at least four migraine days per month. The results from this study were announced by AbbVie, indicating that Atogepant not only met the primary endpoint of fewer adverse event-related treatment discontinuations compared to topiramate but also excelled in all six secondary endpoints, statistically proving its superiority over topiramate in terms of clinical efficacy.

Throughout the 24-week double-blind treatment period, the study showcased that Atogepant had a considerably lower rate of treatment discontinuation due to adverse events (12.1%) when compared to topiramate (29.6%). This underlines the safety and tolerability of Atogepant in comparison to topiramate. Furthermore, Atogepant demonstrated its clinical efficacy by proving that 64.1% of patients achieved a 50% or higher reduction in mean monthly migraine days, surpassing the 39.3% achieved with topiramate.

AbbVie’s Executive Vice President of Research and Development and Chief Scientific Officer, Roopal Thakkar, highlighted the significance of these findings in line with the recommendations put forth by recognized medical organizations such as the American Headache Society and International Headache Society. The study’s outcomes offer concrete evidence of the effectiveness of CGRP pathway inhibitors like Atogepant as primary options for the preventive treatment of migraines.

Migraines often go undiagnosed and undertreated, despite being a prevalent and debilitating neurological condition affecting a substantial portion of the global population. The condition ranks as one of the prominent causes of disability worldwide, necessitating improved treatment options. Particular gaps in patient care surrounding preventive treatments have been identified, with over half of individuals currently using such medications still requiring additional preventive measures for their migraines. The TEMPLE study serves as a response to these challenges, aiming to enhance the standard of care for those grappling with migraines.

Noted neurologist and Founder of Headache Specialists of Oklahoma, Jaclyn Duvall, emphasized how the TEMPLE study’s patient-centered approach to evaluating treatment efficacy and tolerability offers a crucial perspective on real-world outcomes in migraine prevention efforts. The safety profile of Atogepant in the study was consistent with its established safety record from previous trials.

Atogepant, available as AQUIPTA® and QULIPTA®, is an oral CGRP receptor antagonist used for both episodic and chronic migraine prevention in adults, serving as a proven option in 60 countries. Detailed results from the TEMPLE study will be presented at forthcoming medical conferences, further contributing to the understanding of Atogepant’s efficacy and tolerability in migraine prevention.