Biohaven Pharmaceutical said that it has initiated a Phase 1 trial of its BHV-3500, an intranasal calcitonin gene-related peptide (CGRP) receptor antagonist delivered via the Aptar Pharma Unit Dose System after the FDA approved its IND. The trial will evaluate various doses of BHV-3500, which the company is developing for the treatment of migraine.The company announced submission of the IND for BHV-3500 in September 2018.
Biohaven CEO Vlad Coric said, “We are pleased with the FDA’s acceptance of the IND for BHV-3500, and the team at Biohaven is excited to have now dosed our first subject in the Phase 1 clinical trial of this novel CGRP-receptor antagonist. BHV-3500’s intranasal dosing is complementary to our lead migraine asset rimegepant, which has established efficacy and safety in Phase 3 clinical trials. Intranasal BHV-3500 offers the potential for a rapid onset of action without the need for an injection. Our goal is to provide migraine sufferers with a range of noninvasive dosing options for both the acute and preventive treatment of migraine.”
The company’s Chief Development Officer, Neurology, Robert Croop, commented, “People with migraine seek convenient, rapid, long-lasting, and non-invasive treatments. Our development program with both rimegepant and BHV-3500 seeks to provide patients with a range of novel treatment formulations to treat their migraines when and where they attack.”
According to Biohaven, BHV-3500 could be delivered via multiple routes, including inhalation.
Read the Biohaven Pharmaceutical press release.
