Physiologically Based Pharmacokinetic Modeling to Assess Transporter-Mediated Drug-Drug Interactions in Support of Labeling Recommendations for Zavegepant Nasal Spray.

Alice Ke¹, Ernesto Callegari², Manthena V S Varma², Mayur K Ladumor³, Chieko Muto⁴, Richard J Bertz⁵, Hannah M Jones¹, Vaishali Sahasrabudhe², Jing Liu²

¹Certara USA, Radnor, Pennsylvania, USA.

²Pfizer Inc, Groton, Connecticut, USA.

³Pfizer Inc, Collegeville, Pennsylvania, USA.

⁴Pfizer R&D Japan, Tokyo, Japan.

⁵Biohaven Pharmaceuticals, New Haven, Connecticut, USA.

PubMed DOI

Abstract

Zavegepant nasal spray, a calcitonin gene-related peptide receptor antagonist indicated for acute treatment of migraine with or without aura in adults, is a substrate for organic anion transporting polypeptide 1B3 (OATP1B3), Na+/taurocholate cotransporting polypeptide (NTCP), P-glycoprotein (P-gp), and cytochrome P450 3A4 (CYP3A4). In clinical drug-drug interaction (DDI) studies, oral zavegepant e…

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