AbbVie’s TEMPLE Study Shows Atogepant Outperforms Topiramate in Migraine Prevention

AbbVie announces that it will present the latest results from its Phase III TEMPLE head-to-head study at the 2025 International Headache Congress (IHC) in São Paulo, Brazil (September 10th-13th, 2025).

This presentation will highlight results from the multicenter, randomized, double-blind, head-to-face Phase III study evaluating the tolerability, safety, and efficacy of atogepant (60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75, or 100 mg/day) in adult patients with a history of four or more migraine days per month.

AbbVie’s full results presented on September 11th, 2025

“The results of the TEMPLE study highlight the potential of atogepant as an effective and well-tolerated option for the preventive treatment of migraines,” said Luis Nudelman, chief medical officer of AbbVie. “These results address the unmet medical needs of patients seeking preventive treatment options for migraines.”

Results from the TEMPLE study demonstrated that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, achieved superior tolerability and efficacy compared to topiramate, a drug also approved for migraine prevention.

The primary endpoint was treatment discontinuation due to adverse events (AEs), with the AbbVies study demonstrating fewer discontinuations due to adverse events (AEs) with atogepant compared to topiramate. During the 24-week double-blind treatment period, treatment discontinuation due to adverse events was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41.

Additionally, the overall incidence of treatment-emergent adverse events (TEAEs) was lower with atogepant (76.9%) than with topiramate (88.8%), and treatment-related TEAEs in the study were 56.0% for atogepant compared with 77.9% for topiramate.

AbbVie highlights Phase III TEMPLE results, showing atogepant’s superior safety and efficacy over topiramate for migraine prevention

The AbbVie study also met secondary endpoints, including a key measure of clinical efficacy : 64.1% of patients treated with atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period, compared with 39.3% of patients treated with topiramate. This corresponds to a relative risk of 1.63 (95% CI: 1.37-1.95).

The mean reduction in MMD from baseline was -6.27 days for atogepant, compared with -4.49 days for topiramate, with a statistically significant difference of -1.78 days. The demonstrated safety results from the AbbVie’s study were consistent with the known safety profile of atogepant and reinforce it as an effective and well-tolerated treatment option for migraine prevention.

“For people living with migraine, receiving a diagnosis and finding the right treatment can be a long and complex journey,” said Luis Nudelman, Chief Medical Officer of AbbVie. “Furthermore, many patients struggle to meet their treatment goals despite the availability of preventative treatment options. The results of the TEMPLE study underscore the importance of patient access to therapies, such as atogepant, in providing a comprehensive approach to patient care.”

Migraine is a highly prevalent disease affecting one billion people worldwide and is a leading cause of disability for people under the age of 50. People with migraine suffer frequent, disabling attacks, which can prevent them from performing their daily activities, significantly impacting their quality of life. All of this imposes a significant social and financial burden on people living with migraine and healthcare systems.

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(Featured image by Vitaly Gariev via Unsplash)

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