Biohaven announced that the first participant was dosed with BHV-3500, a third generation calcitonin gene-related peptide (CGRP) receptor antagonist. The initiation of dosing follows Biohaven's filing of an investigational new drug application (IND) for BHV-3500 in the treatment of migraine and receipt from FDA of authorization to proceed with the clinical investigation of this product candidate. "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,” Vlad Coric, M.D., CEO of Biohaven, said. “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."
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Biohaven's initial clinical trial of BHV-3500 will explore a range of doses using intranasal administration. Intranasal BHV-3500 utilizes the Aptar Pharma Unit Dose System (UDS), which is designed to enable systemic delivery of drugs without the need for injection or administration by a healthcare professional. This device is approved with multiple drug products marketed in the United States using the Aptar technology and is used by thousands of people every day.
BHV-3500 is the second of Biohaven's CGRP-targeting compounds to enter clinical trials. Biohaven's multiple CGRP product candidates, including rimegepant, and formulations including oral tablet, Zydisâ (Catalent) rapid dissolving tablet and intranasal delivery are designed to meet patients' needs across the spectrum from acute treatment to prevention of migraine.