Atogepant and Sumatriptan: No Clinically Relevant Drug–Drug Interactions in a Randomized, Open-Label, Crossover Trial

Abstract

Aim: To evaluate pharmacokinetic interactions of atogepant with sumatriptan, an open-label, randomized, crossover study was conducted. Patients & methods: Thirty healthy adults received atogepant 60 mg, sumatriptan 100 mg, or coadministered drugs. Primary end point was geometric mean ratios (GMRs) and 90% CIs of interventions for area under the plasma concentration–time curve from time 0 to t (AUC_0-t) or infinity (AUC_0-∞) and peak plasma concentration (C_max). Results: Atogepant GMRs for AUC_0-t and AUC_0-∞ versus with sumatriptan were within 90% CI 0.80–1.25, indicating no interaction; atogepant C_max was reduced by 22% (GMR: 0.78; 90% CI: 0.69–0.89) with sumatriptan. Sumatriptan GMRs for AUC_0-t, AUC_0-∞ and C_max versus with atogepant were within 90% CI 0.80–1.25. Conclusion: Atogepant with sumatriptan had no clinically relevant pharmacokinetic interactions.

Lay abstract

We evaluated the possibility of interactions between atogepant, a new drug for the prevention of migraine, and sumatriptan, a commonly used drug to treat active migraines. A group of 30 healthy adults received atogepant alone, sumatriptan alone or the two drugs taken together, and we measured how the body absorbed, distributed and got rid of the two drugs when given together compared with each drug given alone. There was no indication of any clinically important interactions between atogepant and sumatriptan.

Keywords::

• atogepant
• CGRP receptor antagonist
• clinical trial
• drug–drug interactions
• migraine prevention
• oral
• pharmacokinetics
• sumatriptan

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2021-0073

Author contributions

Study concept and design: R Boinpally, A Jakate, A Periclou. Acquisition of data: A Jakate, M Butler. Analysis and interpretation of data: all authors. Revising the manuscript for intellectual content: all authors. Final approval of the completed manuscript: all authors.

Acknowledgments

The authors thank the study participants, as well as the site/clinical research unit personnel, including clinical and data management staff and the biostatisticians.

Financial & competing interest disclosure

This study was sponsored by Allergan (prior to its acquisition by AbbVie). R Boinpally is an employee of AbbVie and may hold AbbVie stock. A Jakate, M Butler and A Periclou were employees of AbbVie at the time of the study and may hold AbbVie stock. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing and editorial assistance were provided to the authors by L Feder of Peloton Advantage, an OPEN Health company (Parsippany, NJ, USA) and were funded by AbbVie.

Ethical conduct of research

This study was conducted in accordance with the principles of the Declaration of Helsinki and the ICH E6 guideline for Good Clinical Practice. The study protocol was approved by IntegReview IRB (TX, USA). All participants provided written informed consent prior to initiation of study-specific procedures.

Data availability

The authors certify that this manuscript reports original clinical trial data. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

Additional information

Funding

This study was sponsored by Allergan (prior to its acquisition by AbbVie). R Boinpally is an employee of AbbVie and may hold AbbVie stock. A Jakate, M Butler and A Periclou were employees of AbbVie at the time of the study and may hold AbbVie stock. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing and editorial assistance were provided to the authors by L Feder of Peloton Advantage, an OPEN Health company (Parsippany, NJ, USA) and were funded by AbbVie.