Evaluating rimegepant for the treatment of migraine

References

• Headache Classification Committee of the International Headache Society. The International Classification of Headache Disorders. Jan. Cephalalgia. 2018;38(1):1–211. PubMed PMID: 29368949. 3rd edition.
   PubMed Web of Science ®Google Scholar
• Steiner TJ, Stovner LJ, Vos T, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19(1):17. Feb 21; PubMed PMID: 29468450; PubMed Central PMCID: PMCPMC5821623.
   PubMed Web of Science ®Google Scholar
• GBD. Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2016;390(10100):1211–1259. 2017 Sep 16; PubMed PMID: 28919117; PubMed Central PMCID: PMCPMC5605509
   Web of Science ®Google Scholar
• Collaborators GH, Nichols E, Steiner TJ. 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 Nov;17(11):954–976. PubMed PMID: 30353868.
   PubMed Web of Science ®Google Scholar
• Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, CSD, sensitization and modulation of pain. Pain. 2013;(Suppl 1): Dec;154 . 10.1016/j.pain.2013.07.021. PubMed PMID: 24347803; PubMed Central PMCID: PMCPMC3858400.
   Web of Science ®Google Scholar
• Goadsby PJ, Edvinsson L, Ekman R, Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 1990 Aug;28(2):183–187. 10.1002/ana.410280213. PubMed PMID: 1699472.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Edvinsson L. The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats. Ann Neurol. 1993; Jan;33(1):48–56. PubMed PMID: 8388188.
   PubMed Web of Science ®Google Scholar
• Lassen LH, Haderslev PA, Jacobsen VB, et al. CGRP may play a causative role in migraine. Cephalalgia. 2002;22(1):54–61. Feb; PubMed PMID: 11993614.
   PubMed Web of Science ®Google Scholar
• Hansen JM, Hauge AW, Olesen J, et al. Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia. 2010;30(10):1179–1186. Oct; PubMed PMID: 20855363.
   PubMed Web of Science ®Google Scholar
• Juhasz G, Zsombok T, Jakab B et al., Sumatriptan causes parallel decrease in plasma calcitonin gene-related peptide (CGRP) concentration and migraine headache during nitroglycerin induced migraine attack. Cephalalgia 2005 Mar;25(3):179–183. PubMed PMID: 15689192.
   PubMed Web of Science ®Google Scholar
• Ibrahimi K, Danser A, Terwindt GM et al., A human trigeminovascular biomarker for antimigraine drugs: a randomised, double-blind, placebo-controlled, crossover trial with sumatriptan. Cephalalgia 2017 Jan;37(1):94–98. PubMed PMID: 26951335.
   PubMed Web of Science ®Google Scholar
• Labastida-Ramírez A, Rubio Beltrán E, Garrelds IM, et al. Lasmiditan inhibits CGRP release in the mouse trigeminovascular system. Cephalalgia 2017;37:362–363.
   Web of Science ®Google Scholar
• Labastida-Ramírez A, Rubio-Beltrán E, Haanes KA, et al. Lasmiditan inhibits dural CGRP release form the rat trigeminovascular system. MTIS; London 2018.
   Google Scholar
• Olesen J, Diener HC, Husstedt IW. et al., Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004; Mar 11;350(11):1104–1110. PubMed PMID: 15014183.
   PubMed Web of Science ®Google Scholar
• Diener HC, Barbanti P, Dahlof C et al., BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study. Cephalalgia Apr;31(5):573–584. PubMed PMID: 21172952. 2011
   PubMed Web of Science ®Google Scholar
• Hewitt DJ, Aurora SK, Dodick DW et al., Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia Apr;31(6):712–722. PubMed PMID: 21383045. 2011
   PubMed Web of Science ®Google Scholar
• Ho TW, Mannix LK, Fan X. et al., Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology 2008; Apr 15; 70(16):1304–1312. PubMed PMID: 17914062.
   PubMed Web of Science ®Google Scholar
• Connor KM, Shapiro RE, Diener HC. et al., Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology 2009; Sep 22;73(12):970–977. PubMed PMID: 19770473.
   PubMed Web of Science ®Google Scholar
• Ho TW, Connor KM, Zhang Y. et al., Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology 2014 Sep 9; 83(11):958–966. PubMed PMID: 25107879.
   PubMed Web of Science ®Google Scholar
• Biohaven’s NURTEC™ ODT (rimegepant) receives FDA approval for the acute treatment of migraine in adults [Internet]. [cited 2020 Nov 27]. Available from: https://www.prnewswire.com/news-releases/biohavens-nurtec-odt-rimegepant-receives-fda-approval-for-the-acute-treatment-of-migraine-in-adults-301013021.html: PR Newswire; 2020
   Google Scholar
• Allergan receives U.S. FDA approval for UBRELVY™ for the acute treatment of migraine with or without aura in adults [Internet]. Available from: https://www.prnewswire.com/news-releases/allergan-receives-us-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults-300979082.html: PR Newswire; 2019
   Google Scholar
• Biohaven Pharmaceutical Company Holding Ltd. Rimegepant (Nurtec™ ODT): US prescribing information: FDA; 2020 [cited 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212728s000lbl.pdf
   Google Scholar
• Luo G, Chen L, Conway CM. et al., Discovery of (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyri din-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxylate (BMS-927711): an oral calcitonin gene-related peptide (CGRP) antagonist in clinical trials for treating migraine. J Med Chem. 2012 Dec 13;55(23):10644–10651. PubMed PMID: 23153230.
   PubMed Web of Science ®Google Scholar
• Croop R, Ivans A, Stock D, et al. A phase 1 study to evaluate the bioequivalence of oral tablet and orally diossolving tablet formulations of rimegepant, a small molecule CGRP receptor antagonist. 17th Biennial Migraine Trust International Symposium; London, UK 2018.
   Google Scholar
• Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737–745. PubMed PMID: 31311674.
   PubMed Web of Science ®Google Scholar
• Tong G, Savant I, Jariwala N, et al. Phase I single and multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of BMS-927711 in healthy subjects. J Headache Pain. 2013;14(Suppl 1):P118.
   Web of Science ®Google Scholar
• Drugbank. Rimegepant (Accession Number DB12457) 2020 [updated 02-11-2020; cited 2020 27-11-2020]. Available from: https://go.drugbank.com/drugs/DB12457
   Google Scholar
• The Medical Letter on Drugs and Therapeutics. Inhibitors and inducers of CYP enzymes and P-glycoprotein [updated10–09–2020;14–12–2020].
   Google Scholar
• Conway CM, Dubowchik GM, Croop R, et al. Phase 1 and 2 safety, tolerability and pharmacokinetics of single and multiple dose rimegepant as compared to the predicted clinically efficacious dose range. American Headache Society 61st Annual Scientific Meeting; Philadelphia, PA: Biohaven Pharmaceuticals; 2019.
   Google Scholar
• Marcus R, Goadsby PJ, Dodick D, et al. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114–125. PubMed PMID: 23965396.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Croop R, Stock EG, et al. Rimegepant, an Oral Calcitonin Gene–Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142–149. PubMed PMID: 31291516.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Conway CM, Stock EG, et al. Efficacy, safety, and tolerability of rimegepant 75 mg, an oral CGRP receptor antagonist, for the acute treatment of migraine: results from a phase 3, double-blind, randomized, placebo-controlled trial, study 301. American Headache Society 60th Annual Scientific Meeting; San Fransisco CA: Biohaven Pharmaceuticals; 2018.
   Google Scholar
• Gao B, Yang Y, Wang Z, et al. Efficacy and safety of rimegepant for the acute treatment of migraine: evidence from randomized controlled trials. Front Pharmacol. 2020;10:1577. PubMed PMID: 32038251.
   PubMed Web of Science ®Google Scholar
• Croop R, Berman G, Kudrow D, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine (study 201). American Academy of Neurology 2020 Anual Meeting; Virtual Poster 2020.
   Google Scholar
• Mullin K, Kudrow D, Croop R. et al., Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology 2020 May 19;94(20):e2121–e2125. PubMed PMID: 31932515.
   PubMed Web of Science ®Google Scholar
• Berman G, Croop R, Kudrow D. et al., Safety of rimegepant, an oral cgrp receptor antagonist, plus CGRP monoclonal antibodies for migraine. Headache 2020; Aug 16;60(8):1734–1742. PubMed PMID: 32799325.
   PubMed Web of Science ®Google Scholar
• Croop R, Lipton RB, Kudrow D. et al., Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet 2021 Jan 2; 397(10268):51–60. PubMed PMID: 33338437.
   PubMed Web of Science ®Google Scholar
• MaassenVanDenBrink A, Meijer J, Villalón CM, et al. Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci. 2016 Sep;37(9):779–788. PubMed PMID: 27338837.
   PubMed Web of Science ®Google Scholar
• Øie LR, Kurth T, Gulati S et al., Migraine and risk of stroke. J Neurol Neurosurg Psychiatry 2020 Jun;91(6):593–604. PubMed PMID: 32217787.
   PubMed Web of Science ®Google Scholar
• Favoni V, Giani L, Al-Hassany L et al., CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain 2019 Mar 12;20(1):27. PubMed PMID: 30866804.
   PubMed Web of Science ®Google Scholar
• Mulder IA, Li M, De Vries T, et al. Anti-migraine calcitonin gene-related peptide receptor antagonists worsen cerebral ischemic outcome in mice. Ann Neurol. 2020 Oct;88(4):771–784. PubMed PMID: 32583883.
   PubMed Web of Science ®Google Scholar
• Kudrow D, Pascual J, Winner PK. et al., Vascular safety of erenumab for migraine prevention. Neurology 2020 Feb 4;94(5):e497–e510. PubMed PMID: 31852816.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, McAllister P, Ning X et al., Safety and tolerability of fremanezumab for the prevention of migraine: a pooled analysis of phases 2b and 3 clinical trials. Headache Jun;59(6):880–890. PubMed PMID: 30977520. 2019
   PubMed Web of Science ®Google Scholar
• Oakes TM, Kovacs R, Rosen N et al., Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN Studies. Headache 2020 Jan;60(1):110–123. PubMed PMID: 31721185.
   PubMed Web of Science ®Google Scholar
• Ashina M, Goadsby PJ, Reuter U, et al. 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. Jan 5. PubMed PMID: 33400330. 10.1111/ene.14715
   PubMed Web of Science ®Google Scholar
• Pan KS, Siow A, Hay DL, et al. Antagonism of CGRP signaling by rimegepant at two receptors. Front Pharmacol. 2020;11:1240. PubMed PMID: 32973499.
   PubMed Web of Science ®Google Scholar
• Tfelt-Hansen P, Loder LE. The emperor’s new gepants: are the effects of the new oral cgrp antagonists clinically meaningful? Headache. 2019 Jan; 59(1):113–117. PubMed PMID: 30451300.
   PubMed Web of Science ®Google Scholar
• Kirthi V, Derry S, Moore RA Aspirin with or without an antiemetic for acute migraine headaches in adults Cochrane Database Syst Rev 2013 20134 CD008041 Apr 30; PubMed PMID: 23633350.
   Google Scholar
• Derry S, Rabbie R, Moore RA Diclofenac with or without an antiemetic for acute migraine headaches in adults Cochrane Database Syst Rev 2013 20134 CD008783 Apr 30 PubMed PMID: 23633360.
   Google Scholar
• Tfelt-Hansen P, Do TP Is oral telcagepant a relatively slowly acting drug? A mini-review of 4 RCTs. International Headache Conference: Cephalalgia; 2017. p. 81–82.
   Google Scholar
• Conway CM, Croop R, Dubowchik GM, et al. Cardiovascular safety of rimegepant 75 mg in 3 randomized clinical trials and systematic evaluations from in vitro, ex vivo, and in vivo nonclinical assays. American Headache Society 2019 Annual Scientific Meeting; Philadelphia, PA, 2019.
   Google Scholar
• Navratilova E, Behravesh S, Oyarzo J et al., Ubrogepant does not induce latent sensitization in a preclinical model of medication overuse headache. Cephalalgia Aug;40(9):892–902. PubMed PMID: 32615788. 2020
   PubMed Web of Science ®Google Scholar
• Saengjaroentham C, Strother LC, Dripps I. et al., Differential medication overuse risk of novel anti-migraine therapeutics. Brain 2020; Sep 1;143(9):2681–2688. PubMed PMID: 32810212.
   PubMed Web of Science ®Google Scholar
• Rau JC, Navratilova E, Oyarzo J et al., Evaluation of LY573144 (lasmiditan) in a preclinical model of medication overuse headache. Cephalalgia Aug;40(9):903–912. PubMed PMID: 32580575. 2020
   PubMed Web of Science ®Google Scholar
• Holland PR, Saengjaroentham C, Sureda-Gibert P. et al., Medication overuse headache: divergent effects of new acute antimigraine drugs. Cephalalgia. 2020; Aug 40(9): 889–891 PubMed PMID: 32615789
   PubMed Web of Science ®Google Scholar
• Al-Hassany L, Van Den Brink AM. Targeting CGRP in migraine: a matter of choice and dose. Lancet Neurol. Sep;19(9):712–713. PubMed PMID: 32822621. 2020
   PubMed Web of Science ®Google Scholar