An investigational drug application has been filed with the Food and Drug Administration (FDA) for BHV-3500 (Biohaven, New Haven, CT). This new compound is the first intranasal (IN) formulation of a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist to be advanced for clinical trials in humans.
Intranasal BHV-3500 is administered via the Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs, which has been approved for delivery of controlled doses of multiple other drugs. BHV-3500 is a highly soluble and structurally distinct from rimegepant (Biohaven), which is another small molecule CGRP-related drug being investigated for the treatment of migraine.
The chemical properties of BHV-3500 make it potentially suitable for multiple routes of delivery, including nasal, subcutaneous, inhalation, or oral administration. It is initially in development as an intranasal formulation for the acute treatment of migraine. Preliminary proof-of-concept was observed in a preclinical assay with oral delivery. There have been no cardiovascular safety or systemic toxicity issues in preclinical testing.
"People with migraine seek rapid, long-lasting, convenient, and non-invasive treatments. We are pleased to advance BHV-3500 toward first in human dosing and look forward to expanding our current CGRP platform." said Elyse Stock, MD, Chief of Portfolio Strategy and Development. "We believe it is important for migraine sufferers to have a range of dosing options for the acute and preventive treatment of migraine and look forward to expanding our CGRP platform with the addition of intranasal delivery and the potential for rapid onset."Next Story