First Patient Treated in Trial of BHV-3500—A Nasally Delivered CGRP-Receptor Antagonist Being Investigated for Migraine


The first participant has been treated in a clinical trial of BHV-3500 (Biohaven, New Haven, CT) for the treatment of patients with migraine. The first intranasal formulation of a calcitonin gene-related peptide (CGRP)-related drug for migraine, this is the second small-molecule CGRP-related treatment being evaluated by Biohaven in clinical trials. Initiation of this trial follows the Food and Drug Administration’s receipt and authorization of an investigational new drug application (IND) for BHV-3500. A range of doses will be evaluated in this phase 1 trial. 

Administration of BHV-3500 is via the Aptar Pharma Unit Dose System (UDS) designed to enable systemic delivery of drugs. This intranasal delivery system is approved for use with multiple other drugs approved for use in the US. 

Vlad Coric, M.D., CEO of Biohaven, commented, "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." 


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