Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which Biohaven licensed from Bristol-Myers Squibb, is delivered using Aptar Pharma’s unit dose system.
According to the company, no toxicity or safety issues were found during pre-clinical testing in marmosets using oral delivery of the small molecule compound.
Biohaven Chief Scientific Officer Charlie Conway commented, “BHV-3500 has novel properties including high water solubility and a high free fraction which allows for a low dose that we believe is well suited to intranasal delivery. BHV-3500 also exhibits high affinity binding to the human CGRP receptor with a preference to remain bound to the receptor much longer than unbound, and when paired with intranasal administration has the potential for both rapid onset of action and sustained activity.”
Chief of Portfolio Strategy and Development Elyse Stock said, “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.”
The company said that BHV-3500 may also be deliverable by other routes, including inhalation.
Read the Biohaven Pharmaceuticals press release.
