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1 April 2019. A clinical trial is recruiting participants to test a treatment for migraine that delivers the drug as a nasal spray. The large-scale study assessing the drug code-named BHV3500-101 enrolled its first participant, according to its developer Biohaven Pharmaceuticals Inc.
Biohaven Pharmaceuticals in New Haven, Connecticut is a developer of therapies for neurological and psychiatric disorders, with several forms of its BHV3500 treatment for migraine already in clinical trials. Migraine is a neurological syndrome causing severe headaches along with nausea, vomiting, and extreme sensitivity to light and sound. In some cases, migraines are preceded by warning episodes called aura including flashes of light, blind spots, or tingling in arms and legs. The web site Migraine.com estimates 37 million people in the U.S. suffer from migraines, and cites World Health Organization data indicating migraines affect 18 percent of American women and 7 percent of men.
Biohaven’s BHV3500 treatments are in a class of therapies known as calcitonin gene-related peptide, or CGRP receptor antagonists. CGRP peptides are released from neurons during migraine episodes, which activate pain sensors in the brain, contributing to the development and maintenance of persistent pain. CGRP receptor antagonists block pain signals in this pathway, as well as reduce inflammation and dilation of blood vessels that magnify pain signals during migraine episodes.
The company’s latest version of BHV3500 is designed for administration by individuals when they feel the onset of a migraine, without the need for an injection by trained clinicians. In this case, BHV3500-101 is formulated for delivery by a nasal spray, the Pharma Unit Dose System made by Aptar Pharma in Crystal Lake, Illinois. Biohaven says an early-stage trial shows nasal-spray delivery works faster than other CGRP receptor antagonists for migraine, and the safety of BHV3500 treatments are already demonstrated in several other clinical trials.
The Pharma Unit Dose System is designed for immediate use by a patient, in small pre-measured doses and without priming. Drugs sent into the nose are then absorbed through the olfactory sensory nerves into the brain. Several Aptar nasal spray systems are cleared by FDA, including a device authorized last month for delivery of antidepressant drugs.
The intermediate- and late-stage clinical trial is testing BHV3500-101 among 1,600 individuals with a history of migraines at 80 sites in the U.S. Participants are randomly assigned to receive BHV3500 doses with the Aptar nasal spray device in doses of 5, 10, or 20 milligrams, or a placebo. The study team is looking primarily at pain and migraine symptom relief, such as light and sound sensitivity within 2 hours of taking the drug, as measured on standard self-reported scales. The researchers are also measuring a number of other self-reported indicators of pain and migraine symptoms, as well as disability and quality of life measures.
“This is the first late-stage clinical trial designed to assess the efficacy of an intranasally administered CGRP receptor antagonist in the acute treatment of migraine,” says Biohaven CEO Vlad Coric in a company statement. Coric adds, “We believe that intranasal BHV-3500 may provide people with ultra-rapid onset of migraine relief in a form that can easily be self-administered whenever and wherever a migraine strikes.” The company expects to report top-line results by the end of 2019.
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