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Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016.
Lancet Neurol. 2018; 17: 954-976
The international classification of headache disorders, 3rd Edition.
Cephalalgia. 2018; 38: 1-211
CGRP as the target of new migraine therapies—successful translation from bench to clinic.
Nat Rev Neurol. 2018; 14: 338-350
Targeting calcitonin gene-related peptide: a new era in migraine therapy.
Lancet. 2019; 394: 1765-1774
Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment?.
Curr Opin Neurol. 2020; 33: 309-315
Ubrogepant (Ubrelvy™): US prescribing information.
Office of Clinical Pharmacology Review. Clinical Pharmacology Review(s).
Rimegepant (Nurtec™ ODT): US prescribing information.
Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial.
Lancet. 2021; 397: 51-60
Atogepant has no clinically relevant effects on the pharmacokinetics of an ethinyl estradiol/levonorgestrel oral contraceptive in healthy female participants.
J Clin Pharmacol. 2020; 60: 1157-1165
Atogepant.
Vazegepant.
Vazegepant hydrochloride.
Erenumab (Aimovig™): US prescribing information.
Fremanezumab (AjovyTM): US prescribing information.
Galcanezumab (EmgalityTM): US prescribing information.
Eptinezumab (VyeptiTM): US prescribing information.
Baker B, Hodsman P, Smith JPK. SPK & PD supporting a single dose, placebo-controlled randomized ascending dose study of ALD403, a humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered IV or SC. 17th Congress of the International Headache Society; Valencia, Spain; May 2015.
BDDCS, the Rule of 5 and drugability.
Adv Drug Deliv Rev. 2016; 101: 89-98
Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system.
Pharm Res. 2005; 22: 11-23
The role of BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system) in drug development.
J Pharm Sci. 2013; 102: 34-42
Volumes of distribution.
J Vet Pharmacol Ther. 2004; 27: 441-453
Pharmacokinetics.
Biochem Pharmacol. 2014; 87: 93-120
Volume of distribution.
StatPearls Publishing,
Treasure Island2019
Cytochrome P450 3A (including 3A4) inhibitors and inducers.
Inhibitors and inducers of P-glycoprotein (P-gp) drug efflux pump (P-gp multidrug resistance transporter).
Drug development and drug interactions: table of substrates, inhibitors and inducers.
A second trigeminal CGRP receptor: function and expression of the AMY1 receptor.
Ann Clin Transl Neurol. 2015; 2: 595-608
Calcitonin gene-related peptide modulators—the history and renaissance of a new migraine drug class.
Headache. 2019; 59: 951-970
Characterization of ubrogepant: a potent and selective antagonist of the human calcitonin gene-related peptide receptor.
J Pharmacol Exp Ther. 2020; ()
Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies.
Cephalalgia. 2015; 35: 118-131
Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment of migraine.
Headache. 2004; 44: 414-425
Cardiovascular effects and safety of (non-aspirin) NSAIDs.
Nat Rev Cardiol. 2020; 17: 574-584
Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.
Cephalalgia. 2021; 41: 979-990
Single therapeutic and supratherapeutic doses of ubrogepant do not affect cardiac repolarization in healthy adults: results from a randomized trial.
Clin Pharmacol Ther. 2020; 107: 1014-1022
Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial.
Headache. 2020; 60: 141-152
Ubrogepant.
Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial.
JAMA. 2019; 322: 1887-1898
Ubrogepant for the treatment of migraine.
N Engl J Med. 2019; 381: 2230-2241
Absence of clinically significant drug interactions with coadministration of ubrogepant and an ethinyl estradiol/norgestimate oral contraceptive in healthy female subjects: a phase 1 pharmacokinetic analysis.
Neurology. 2019; 92: 10-18
Coadministration of single therapeutic oral doses of ubrogepant and sumatriptan produces no clinically relevant pharmacokinetic interactions.
Headache. 2019; 59: 86-87
Evaluation of the pharmacokinetic interaction and safety of ubrogepant coadministered with acetaminophen or nonsteroidal anti-inflammatory drugs: a randomized trial.
Cephalalgia Rep. 2020; 3: 1-10
Food effects on oral drug absorption: application of physiologically-based pharmacokinetic modeling as a predictive tool.
Pharmaceutics. 2020; 12: 672
Functional significance of genetic polymorphisms in P-glycoprotein (MDR1, ABCB1) and breast cancer resistance protein (BCRP, ABCG2).
Drug Metab Pharmacokinet. 2012; 27: 85-105
Antagonism of CGRP signaling by rimegepant at two receptors.
Front Pharmacol. 2020; 111240
Malnutrition in the elderly.
Sci Progress. 2019; 102: 171-180
Migraine prevalence in eating disorders and pathophysiological correlations.
Neurol Sci. 2009; 30: S55-S59
Conway CM, Croop R, Dubowchik GM, Coric V, Lipton RB. Cardiovascular safety of rimegepant 75 mg in 3 randomized clinical trials and systematic evaluations from in vitro, ex vivo, and in vivo nonclinical assays. 61st Annual Scientific Meeting American Headache Society; Philadelphia; July 11–14, 2019.
Rimegepant 75 mg exposure, safety, and tolerability are similar in elderly and nonelderly adults: a phase 1, open-label, parallel-group, single-dose study (2101).
Neurology. 2020; 94
Rimegepant 75 mg demonstrates safety and tolerability similar to placebo with no effects of age, sex, or race in 3 phase 3 trials (1609).
Neurology. 2020; 941609
Pharmacokinetics, pharmacodynamics and drug–drug interactions of new anti-migraine drugs—lasmiditan, gepants, and calcitonin-gene-related peptide (CGRP) receptor monoclonal antibodies.
Pharmaceutics. 2020; 12: 1-22
Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study.
Neurology. 2019; 92: S17.001
Targeting CGRP in migraine: a matter of choice and dose.
Lancet Neurol. 2020; 19: 712-713
Pharmacokinetics and safety of single-dose atogepant in participants with hepatic impairment.
Headache. 2020; 60: 45-46
Single-dose pharmacokinetics and safety of atogepant in adults with hepatic impairment: results from an open-label, phase 1 trial.
Clin Pharmacol Drug Dev. 2021; 10: 726-733
Zavegepant.
Biohavan pharmaceuticals. Biohaven achieves positive topline results in pivotal phase 2/3 study of vagezepant, the first and only intranasal CGRP receptor antagonist in clinical development for the acute treatment of migraine. 2021 (accessed Dec 18, 2021).
Efficacy of ubrogepant based on prior exposure and response to triptans: A post hoc analysis.
Headache. 2021; 61: 422-429
Rimegepant for the acute treatment of migraine in patients with a history of triptan treatment failure: pooled results from 3 phase 3 clinical trials.
Neurology. 2021; 964914
BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial.
Cephalalgia. 2014; 34: 114-125
Characterisation of the calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human isolated coronary, cerebral and middle meningeal arteries.
Cephalalgia. 2020; 40: 357-366
Sex differences in response to triptans: a systematic review and meta-analysis.
Neurology. 2021; 96: 162-170
Sex is a major determinant of CYP3A4 expression in human liver.
Hepatology. 2003; 38: 978-988
Polymorphism in cytochrome P450 3A4 is ethnicity related.
Front Genet. 2019; 10: 224
Effect of obesity on the pharmacokinetics of drugs in humans.
Clin Pharmacokinet. 2010; 49: 71-87
The influence of age and sex on the clearance of cytochrome P450 3A substrates.
Clin Pharmacokinet. 2005; 44: 33-60
Pharmacokinetics of drugs in cachectic patients: a systematic review.
PLoS One. 2013; 8e79603
Human variability in CYP3A4 metabolism and CYP3A4-related uncertainty factors for risk assessment.
Food Chem Toxicol. 2003; 41: 201-224
The influence of age and sex on the clearance of cytochrome P450 3A substrates.
Clin Pharmacokinet. 2005; 44: 33-60
Erenumab efficacy in highly resistant chronic migraine: a real-life study.
Neurol Sci. 2020; 41: 457-459
Sustained efficacy and safety of erenumab in patients with episodic migraine who failed 2–4 prior preventive treatments: 2-year interim results of the LIBERTY open-label extension study.
Eur J Neurol. 2020; 27: 1298-1299
Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study.
Cephalalgia. 2019; 39: 817-826
Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial.
Eur J Neurol. 2021; 28: 1716-1725
Real-world patient experience with erenumab for the preventive treatment of migraine.
Headache. 2020; 60: 2014-2025
Effect of fremanezumab monthly and quarterly doses on efficacy responses.
Headache. 2020; 60: 1376-1391
Early efficacy in patients ≥60 years of age with episodic or chronic migraine: pooled results of 3 randomised, doubleblind, placebo-controlled phase 3 studies.
Eur J Neurol. 2020; 27: 162
No “wearing-off effect” seen in quarterly or monthly dosing of fremanezumab: subanalysis of a randomized long-term study.
Headache. 2020; 60: 2431-2443
Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: a phase 2 randomized controlled clinical trial.
Cephalalgia Rep. 2020; 3: 1-10
Population pharmacokinetics of galcanezumab, an anti-CGRP antibody, following subcutaneous dosing to healthy individuals and patients with migraine.
J Clin Pharmacol. 2020; 60: 229-239
Pharmacokinetic–pharmacodynamic relationship of erenumab (AMG 334) and capsaicin-induced dermal blood flow in healthy and migraine subjects.
Pharm Res. 2017; 34: 1784-1795
Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine.
Br J Clin Pharmacol. 2019; 85: 2721-2733
Immunogenicity of biologic therapies for migraine: a review of current evidence.
J Headache Pain. 2021; 22: 3
How obesity could create problems for a COVID vaccine.
Nature. 2020; 586: 488-489
Migraine therapeutics differentially modulate the CGRP pathway.
Cephalalgia. 2021; 41: 499-514
Wiping Out CGRP: potential cardiovascular risks.
Trends Pharmacol Sci. 2016; 37: 779-788
Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: analysis of the WHO pharmacovigilance database.
Cephalalgia. 2021; 41: 789-798
Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine.
Regul Toxicol Pharmacol. 2019; 106: 224-238
IgG placental transfer in healthy and pathological pregnancies.
Clin Dev Immunol. 2012; 2012985646
Cgrp monoclonals: Efficacy, side effects, and switching.
Headache. 2020; 60: 8-9
A real-world comparison of erenumab and galcanezumab in a tertiary headache center.
Headache. 2020; 60: 4-5
Erenumab efficacy in chronic migraine and medication overuse: a real-life multicentric Italian observational study.
Neurol Sci. 2020; 41: 489-490
The impact of fremanezumab on medication overuse in patients with chronic migraine.
J Headache Pain. 2020; 21: 10-26
Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine.
Cephalalgia. 2021; 41: 340-352
Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: subgroup analysis of PROMISE-2.
Headache. 2021; 61: 125-136
Migraine response in patients with migraine receiving eptinezumab treatment: consistency throughout the PROMISE-1 and PROMISE-2 trials.
Headache. 2020; 60: 113-114
CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP?.
J Headache Pain. 2019; 20: 27
The role of calcitonin gene related peptide (CGRP) in neurogenic vasodilation and its cardioprotective effects.
Front Physiol. 2018; 91249
Blocking CGRP in migraine patients—a review of pros and cons.
J Headache Pain. 2017; 18: 96
Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study.
Headache. 2021; 61: 363-372
Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study).
J Headache Pain. 2021; 22: 35
Sex differences in pharmacokinetics and pharmacodynamics.
Clin Pharmacokinet. 2009; 48: 143-157
Gender aspects of CGRP in migraine.
Cephalalgia. 2019; 39: 435-444
Changing levels of sex hormones and calcitonin gene-related peptide (CGRP) during a woman’s life: implications for the efficacy and safety of novel antimigraine medications.
Maturitas. 2021; 145: 73-77
Migraine headaches and preeclampsia: an epidemiologic review.
Headache. 2006; 46: 794-803
Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene–related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: a randomized phase 1b drug–drug interaction study.
Headache. 2021; 61: 642-652
Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy.
Neurology. 2020; 94: e2121-e2125
Safety profile of the triptans.
Expert Opin Drug Saf. 2003; 2: 123-132
Lasmiditan (Reyvow™): US prescribing information.
Drug interactions due to cytochrome P450.
Proc Bayl Univ Med Cent. 2000; 13: 421-423
Choosing the safest acute therapy during chronic migraine prophylactic treatment: pharmacokinetic and pharmacodynamic considerations.
Expert Opin Drug Metab Toxicol. 2016; 12: 399-406
The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats.
Ann Neurol. 1993; 33: 48-56
Sumatriptan causes parallel decrease in plasma calcitonin gene-related peptide (CGRP) concentration and migraine headache during nitroglycerin induced migraine attack.
Cephalalgia. 2005; 25: 179-183
Association between response to triptans and response to erenumab: real-life data.
J Headache Pain. 2021; 22: 1
Phase I, randomized, double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients with migraine.
Clin Pharmacol Ther. 2018; 103: 815-825
Amylin analog pramlintide induces migraine-like attacks in patients.
Ann Neurol. 2021; 89: 1157-1171
Distinct patterns of internalization of different calcitonin gene-related peptide receptors.
ACS Pharmacol Transl Sci. 2020; 3: 296-304
Effects of monoclonal antagonist antibodies on calcitonin gene-related peptide receptor function and trafficking.
J Headache Pain. 2019; 20: 44
CGRP, amylin, immunology, and headache medicine.
Headache. 2019; 59: 131-150
Predicting erenumab adverse events with single-cell genomics.
Lancet. 2020; 396: 95-96
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