819
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Effects of CYP3A4 Inhibition/Induction and OATP Inhibition on the Pharmacokinetics of Atogepant in Healthy Adults

ORCID Icon, , &
Pages 445-456 | Received 24 May 2023, Accepted 08 Aug 2023, Published online: 31 Aug 2023

References

  • Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet392(10159), 1789–1858 (2018).
  • Burch R , RizzoliP , LoderE. The prevalence and impact of migraine and severe headache in the United States: updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache61(1), 60–68 (2021).
  • Katsarava Z , ManackA , YoonMSet al. Chronic migraine: classification and comparisons. Cephalalgia31(5), 520–529 (2011).
  • Maideen NMP , RajkapoorB , MuthusamyS , RamanathanS , ThangaduraiSA , SughirAA. A review on pharmacokinetic and pharmacodynamic drug interactions of adrenergic β-blockers with clinically relevant drugs - an overview. Curr. Drug Metab.22(9), 672–682 (2021).
  • AbbVie Canada . UBRELVY product monograph. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/UBRELVY_PM_EN.pdf (Accessed 20May2023).
  • AbbVie . Prescribing Information: qulipta (atogepant) tablets, for oral use (2023). https://www.rxabbvie.com/pdf/QULIPTA_pi.pdf
  • Charles A , Pozo-RosichP. Targeting calcitonin gene-related peptide: a new era in migraine therapy. Lancet394(10210), 1765–1774 (2019).
  • Ailani J , LiptonRB , GoadsbyPJet al. Atogepant for the preventive treatment of migraine. N. Engl. J. Med.385(8), 695–706 (2021).
  • Cohen F , YuanH , SilbersteinSD. Calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies and antagonists in migraine: current evidence and rationale. BioDrugs36(3), 341–358 (2022).
  • Villalón CM , OlesenJ. The role of CGRP in the pathophysiology of migraine and efficacy of CGRP receptor antagonists as acute antimigraine drugs. Pharmacol. Ther.124(3), 309–323 (2009).
  • Edvinsson L . The trigeminovascular pathway: role of CGRP and CGRP receptors in migraine. Headache57(Suppl. 2), 47–55 (2017).
  • Alpuente A , GallardoVJ , AsskourL , CaronnaE , Torres-FerrusM , Pozo-RosichP. Salivary CGRP and erenumab treatment response: towards precision medicine in migraine. Ann. Neurol.92(5), 846–859 (2022).
  • de Vries Lentsch S , GarreldsIM , DanserAHJ , TerwindtGM , MaassenVanDenBrinkA. Serum CGRP in migraine patients using erenumab as preventive treatment. J. Headache Pain.23(1), 120 (2022).
  • Goadsby PJ , EdvinssonL. The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats. Ann. Neurol.33(1), 48–56 (1993).
  • Min KC , KraftWK , BondiskeyPet al. Atogepant is not associated with clinically meaningful alanine aminotransferase elevations in healthy adults. Clin. Transl. Sci.14(2), 599–605 (2021).
  • Boinpally R , McNameeB , YaoLet al. A single supratherapeutic dose of atogepant does not affect cardiac repolarization in healthy adults: results from a randomized, single-dose, phase I crossover trial. Clin. Pharmacol. Drug Dev.10(9), 1099–1107 (2021).
  • Boinpally R , JakateA , ButlerM , BorbridgeL , PericlouA. single-dose pharmacokinetics and safety of atogepant in adults with hepatic impairment: results from an open-label, phase I trial. Clin. Pharmacol. Drug Dev.10(7), 726–733 (2021).
  • Goadsby PJ , DodickDW , AilaniJet al. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase IIb/3 trial. Lancet Neurol.19(9), 727–737 (2020).
  • Pozo-Rosich P , AilaniJ , AshinaMet al. Atogepant for the Preventive Treatment of Chronic Migraine: Results From the PROGRESS Phase 3 Trial. Lancet DOI: 10.1016/S0140-6736(23)01049-8 (2023) ( Online ahead of print).
  • Rustichelli C , AvalloneR , FerrariA. Atogepant: an emerging treatment for migraine. Expert Opin. Pharmacother.23(6), 653–662 (2022).
  • Vossen M , SevestreM , NiederaltC , JangIJ , WillmannS , EdgintonAN. Dynamically simulating the interaction of midazolam and the CYP3A4 inhibitor itraconazole using individual coupled whole-body physiologically-based pharmacokinetic (WB-PBPK) models. Theor. Biol. Med. Model.4, 13 (2007).
  • Vavricka SR , Van MontfoortJ , HaHR , MeierPJ , FattingerK. Interactions of rifamycin SV and rifampicin with organic anion uptake systems of human liver. Hepatology36(1), 164–172 (2002).
  • Venkatesan K . Pharmacokinetic drug interactions with rifampicin. Clin. Pharmacokinet.22(1), 47–65 (1992).
  • Lau YY , HuangY , FrassettoL , BenetLZ. Effect of OATP1B transporter inhibition on the pharmacokinetics of atorvastatin in healthy volunteers. Clin. Pharmacol. Ther.81(2), 194–204 (2007).
  • Backman JT , LuurilaH , NeuvonenM , NeuvonenPJ. Rifampin markedly decreases and gemfibrozil increases the plasma concentrations of atorvastatin and its metabolites. Clin. Pharmacol. Ther.78(2), 154–167 (2005).
  • US Food and Drug Administration . Drug Development and drug interactions | table of substrates, inhibitors and inducers. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers (Accessed 18July2023).
  • Zheng HX , HuangY , FrassettoLA , BenetLZ. Elucidating rifampin’s inducing and inhibiting effects on glyburide pharmacokinetics and blood glucose in healthy volunteers: unmasking the differential effects of enzyme induction and transporter inhibition for a drug and its primary metabolite. Clin. Pharmacol. Ther.85(1), 78–85 (2009).