In a phase 1 clinical trial, it was shown that intranasal delivery of a third-generation calcitonin gene-related peptide antagonist reached therapeutic levels in treated participants. The drug, BHV-3500 (Biohaven, New Haven, CT) is the first intranasal formulation of a CGRP antagonist and is being studied for acute treatment of migraine and is also suitable for delivery as an oral or inhaled agent. Phase 2 clinical trials are expected to begin later this year.
The Phase 1 trial explored a broad dose range to characterize the pharmacokinetic (PK) profile and initial safety of the drug in humans. The preliminary PK profile achieved targeted therapeutic exposures with a shorter time to maximal concentration (Tmax) than other small-molecule CGRP receptor antagonists.
"We are excited to report that intranasal administration of BHV-3500 in our Phase 1 trial achieved drug exposures that we believe will be therapeutic in the acute treatment of migraine,” said Vlad Coric, MD, CEO of Biohaven Pharmaceutical Holding Company Ltd. “Additionally, the PK profile of intranasal BHV-3500 demonstrated the earliest Tmax that we have observed with a small molecule CGRP receptor antagonist and suggests the potential for an ultra-rapid onset of action without the need for an injection.”
James Geyer, MD, and Paul Cox
F. Stephen Benesh, MD, and Shruti P. Agnihotri, MD
Michelle L. Dougherty, MD, FAES, FAAN