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High-fat meals have an insignificant effect on the pharmacokinetics of immediate release atogepant tablets, which does not clinically impact the drug’s ability to prevent episodic migraine in adults. These study findings were presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from June 9-June 12, in Denver, Colorado, and virtually.
Atogepant, an oral calcitonin gene-related peptide receptor antagonist, obtained US Food and Drug Administration approval to prevent episodic migraine in adults.
Researchers conducted a single-center, open-label, 2-period, randomized crossover study in which 20 healthy adults took a single 60 mg dose of atogepant to understand how a high-fat meal impacted systemic exposure to the drug, and thus, potentially, its efficacy.
During the first period of the study, some of the participants took atogepant after fasting overnight, while the others consumed a high-fat meal 30 minutes prior to taking the medication. Following a 7-day washout period, each of the study participants received the opposite treatment regimen during the second period of the study.
The researchers obtained plasma samples prior to dosing and up to 48 hours following dosing at specified time intervals to determine atogepant plasma concentrations and various pharmacokinetic parameters, including maximum plasma concentration (Cmax) and the area under the curve (AUC).
After statistical analysis, a high-fat meal decreased maximum atogepant concentration levels by 22% and decreased the AUC by 18%. No serious adverse events or deaths occurred during the trial, indicating that single dose of 60 mg of atogepant was safe and tolerated well under both fed and fasted states.
A high-fat meal did cause a mild food effect on the pharmacokinetics of atogepant; however, the researchers determined that this small food effect did not make a significant difference on the efficacy of the drug.
Since “atogepant [is] a preventive treatment for migraine with a wide effective dose range of 10 to 60 mg/day, the mild food effect on its [pharmacokinetics] is not considered clinically relevant,” the researchers concluded.
Reference
Boinpally R, Trugman JM. Effect of high fat meal on the pharmacokinetics of an immediate release atogepant tablet. Presented at: AHS 2022 Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado. Poster 118.
This article originally appeared on Neurology Advisor
