Evidence map›Paper›PMID 41105969›Full record

ArticleClinical and translational science2025

Exposure Matching Using Population Pharmacokinetic Modeling and Simulation to Support Rimegepant Dose Selection for Pediatric Patients With Migraine.

Craig M Comisar, Jim H Hughes, Gary Mo, Rajinder Bhardwaj, Abhijeet Jakate, Chay Ngee Lim, Jing Liu

Abstract read
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Craig M ComisarCertara, Princeton, New Jersey, USA.
Jim H HughesPfizer Inc., Groton, Connecticut, USA.ORCID 0000-0002-1862-5805
Gary MoPfizer Inc., La Jolla, California, USA.ORCID 0000-0001-7805-5077
Rajinder BhardwajCertara, Princeton, New Jersey, USA.
Abhijeet JakatePfizer Inc., New York, New York, USA.ORCID 0009-0000-2196-5782
Chay Ngee LimPfizer Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-7307-9851
Jing LiuPfizer Inc., Groton, Connecticut, USA.ORCID 0000-0001-9481-5961

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rimegepant is a small molecule calcitonin gene-related peptide receptor antagonist approved as a 75 mg orally disintegrating tablet for the acute treatment of migraine and the prevention of episodic migraine in adults. A population pharmacokinetic model for oral rimegepant was previously developed using data from 11 phase I studies in adults. This analysis updated the population pharmacokinetic model with data from one pediatric (20 participants) and two adult (74 participants) studies. The resultant population pharmacokinetic model was used to predict rimegepant exposure following single or every-other-day dosing in a virtual pediatric population generated using United States national growth charts. Exposure with rimegepant 75 mg orally disintegrating tablet was evaluated in simulated participants aged 6 to 17 years (1000 simulations/1-year age group), and exposure with rimegepant 25, 35, 50, and 75 mg was evaluated in simulated participants weighing 9 to 75 kg (1000 simulations/5 kg increment). Rimegepant doses for pediatric patients were selected using predicted pediatric/adult exposure ratios close to 1 and ≤ 2. The recommended single and every-other-day doses of rimegepant orally disintegrating tablet in the pediatric population were 75 mg in adolescents 12 to < 18 years of age and children 6 to < 12 years of age and with a body weight > 40 kg; 50 mg in children 6 to < 12 years of age with a body weight > 25 to ≤ 40 kg; and 35 mg in children 6 to < 12 years of age with a body weight > 15 to ≤ 25 kg. These selected doses will support further evaluation of rimegepant efficacy and safety in pediatric patients with migraine.

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersModels, BiologicalPiperidinesPyridinesAdministration, OralAdolescentAdultChildComputer SimulationDose-Response Relationship, DrugFemaleHumansMaleTabletsCalcitonin Gene-Related Peptide Receptor AntagonistsPiperidinesPyridinesrimegepant sulfateTabletsexposure matchingmigrainepediatricpopulation pharmacokinetic modelingrimegepant

Identifiers

PMID41105969
PMCPMC12534026

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.