2022
P‐Glycoprotein and Breast Cancer Resistance Protein Transporter Inhibition by Cyclosporine and Quinidine on the Pharmacokinetics of Oral Rimegepant in Healthy Subjects
Bhardwaj R, Collins J, Stringfellow J, Madonia J, Anderson M, Finley J, Stock D, Coric V, Croop R, Bertz R. P‐Glycoprotein and Breast Cancer Resistance Protein Transporter Inhibition by Cyclosporine and Quinidine on the Pharmacokinetics of Oral Rimegepant in Healthy Subjects. Clinical Pharmacology In Drug Development 2022, 11: 889-897. PMID: 35304977, PMCID: PMC9311059, DOI: 10.1002/cpdd.1088.Peer-Reviewed Original ResearchConceptsBreast cancer resistance protein transporterPlasma concentration-time curveSingle oral doseGeometric mean ratiosConcentration-time curveP-glycoproteinOral doseHealthy subjectsSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistStrong P-glycoprotein inhibitorBreast cancer resistance protein (BCRP) inhibitionPeptide receptor antagonistTime 0Mean ratioP-glycoprotein inhibitorsP-glycoprotein transporterConcomitant administrationCrossover studyReceptor antagonistPreventive treatmentCyclosporineCoadministrationTransporter inhibitionPharmacokineticsRimegepant 75 mg for acute treatment of migraine is associated with significant reduction in monthly migraine days: Results from a long-term, open-label study
L’Italien G, Popoff E, Johnston K, McGrath D, Conway C, Powell L, Harris L, Kowalczyk N, Croop R, Coric V. Rimegepant 75 mg for acute treatment of migraine is associated with significant reduction in monthly migraine days: Results from a long-term, open-label study. Cephalalgia Reports 2022, 5: 25158163221075596. DOI: 10.1177/25158163221075596.Peer-Reviewed Original ResearchMonthly migraine daysBaseline monthly migraine daysAcute treatmentMigraine daysMedian timeMigraine frequencyOral calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistOpen-label safety studyBaseline migraine frequencyCGRP receptor blockadeOpen-label studyPeptide receptor antagonistMMD reductionReceptor blockadeMigraine attacksReceptor antagonistPreventive treatmentOutcome measuresResponse rateMigraineSafety studiesTreatmentStudy objectiveSignificant reduction
2021
Matching‐adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health‐related quality of life in the treatment of migraine
Popoff E, Johnston K, Croop R, Thiry A, Harris L, Powell L, Coric V, L’Italien G, Moren J. Matching‐adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health‐related quality of life in the treatment of migraine. Headache The Journal Of Head And Face Pain 2021, 61: 906-915. PMID: 34021585, PMCID: PMC8361942, DOI: 10.1111/head.14128.Peer-Reviewed Original ResearchConceptsMonthly migraine daysMatching-adjusted indirect comparisonHealth-related qualityEVOLVE trialSTRIVE trialBaseline characteristicsMigraine daysIndirect comparisonSmall-molecule calcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptor antagonistLong-term preventive effectsAnti-CGRP monoclonal antibodiesMean differencePlacebo-controlled trialPeptide receptor antagonistSingle-arm trialTreatment of migraineVersion 2 scoreMigraine-Specific QualityAssessment test scoreAcute treatmentRandomized trialsWeek 12HRQoL dataReceptor antagonist
2020
Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial
Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. The Lancet 2020, 397: 51-60. PMID: 33338437, DOI: 10.1016/s0140-6736(20)32544-7.Peer-Reviewed Original ResearchConceptsDouble-blind treatment phasePlacebo-controlled trialStudy medicationMigraine daysPreventive treatmentAdverse eventsPhase 2/3Observation periodTreatment phaseWeek 9Calcitonin gene-related peptide receptor antagonistMean numberInteractive web response systemPrimary efficacy endpointWeb response systemPeptide receptor antagonistEfficacy endpointPrimary endpointAcute treatmentEligible participantsReceptor antagonistPlaceboMigraineMedicationsRimegepantSafety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine
Berman G, Croop R, Kudrow D, Halverson P, Lovegren M, Thiry A, Conway C, Coric V, Lipton R. Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Headache The Journal Of Head And Face Pain 2020, 60: 1734-1742. PMID: 32799325, PMCID: PMC7496574, DOI: 10.1111/head.13930.Peer-Reviewed Original ResearchConceptsCGRP receptor antagonistSmall molecule CGRP receptor antagonistsTreatment adverse eventsCGRP mAbsAdverse eventsAcute treatmentPreventive treatmentReceptor antagonistCalcitonin gene-related peptide (CGRP) ligandOral CGRP receptor antagonistLong-term safety studiesMonoclonal antibodiesCGRP monoclonal antibodiesMonthly migraine attacksOral acute treatmentSevere pain intensitySerious adverse eventsLarger patient populationPrevious case reportsModerate nasopharyngitisStable doseAminotransferase levelsPain intensityAdditional patientsPreventive regimenPotential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy
Mullin K, Kudrow D, Croop R, Lovegren M, Conway C, Coric V, Lipton R. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology 2020, 94: 10.1212/wnl.0000000000008944. PMID: 31932515, PMCID: PMC7526667, DOI: 10.1212/wnl.0000000000008944.Peer-Reviewed Original ResearchConceptsSmall molecule CGRP receptor antagonistsCGRP receptor antagonistAcute treatmentReceptor antagonistReceptor antibodiesLong-term safety studiesClass IV evidenceRelated adverse eventsFirst clinical reportDrug Administration approvalYears of ageInjectable ketorolacRefractory migraineAcute attacksAdverse eventsSuboptimal responseMigraine medicationsPreventive administrationMigraine therapyPatient 1Patient 2Women 44Case reportConcomitant usePreventive treatment
2019
Rimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine
Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine. New England Journal Of Medicine 2019, 381: 142-149. PMID: 31291516, DOI: 10.1056/nejmoa1811090.Peer-Reviewed Original ResearchConceptsPercentage of patientsPeptide receptor antagonistPlacebo groupMigraine attacksBothersome symptomsReceptor antagonistCalcitonin gene-related peptide receptor antagonistCalcitonin gene-related peptide receptorGene-related peptide receptorOral Calcitonin GeneSingle migraine attackAcute migraine treatmentCommon adverse eventsPrimary end pointPhase 3 trialUrinary tract infectionOverall mean agePathogenesis of migraineModified intentionAdverse eventsTract infectionsTreat analysisMean ageMigraine treatmentCalcitonin gene
2010
Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder
Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang S, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double‐blind, active comparator and placebo‐controlled trial of a corticotropin‐releasing factor receptor‐1 antagonist in generalized anxiety disorder. Depression And Anxiety 2010, 27: 417-425. PMID: 20455246, DOI: 10.1002/da.20695.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAnti-Anxiety AgentsAnxiety DisordersCitalopramDiagnostic and Statistical Manual of Mental DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedPharmacogeneticsPhenotypePolymorphism, Single NucleotidePsychometricsPyrazolesReceptors, Corticotropin-Releasing HormoneSeverity of Illness IndexTriazinesYoung AdultConceptsGeneralized anxiety disorderSingle nucleotide polymorphismsHamilton Anxiety Scale (HAMA) total scoreAnxiety disordersFactor receptor 1 antagonistActive comparator armCorticotropin-releasing factor receptorsActive comparator trialsPlacebo-controlled trialCorticotropin-releasing factor receptor 1 antagonistTreatment of GADPrimary outcome measurePlexin-A2Receptor 1 antagonistScale total scoreCRF-1 receptor antagonistClass of agentsComparator trialsComparator armPrimary outcomeActive comparatorEntire cohortRandomized subjectsReceptor antagonistMean change