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Trial Shows Nasal Spray Relieves Migraine Pain

Nasal spray

(Wikimedia Commons)

6 Dec. 2021. Clinical trial results show a nasal spray treatment for acute migraine helps more users achieve relief from pain within two hours, and faster in some cases. Biohaven Pharmaceutical Holding Co. in New Haven, Connecticut reported summary data from the trial today on its web site, but the findings are not yet peer reviewed.

Migraine is a common 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. According to Migraine Research Foundation, some 1 billion people worldwide, including 39 million in the U.S., experience migraines. The disorder affects nearly one in four U.S. households, with three times as many women experiencing migraines than men, as well as 10 percent of children.

Biohaven Pharma is a developer of therapies for neurological and psychiatric disorders, with the oral drug rimegepant, marketed as Nurtec ODT, already approved by Food and Drug Administration to prevent and treat migraine. The company says zavegepant is its next-generation migraine drug formulated as a nasal spray. Zavegepant is 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 says zavegepant is a highly soluble formulation taken when experiencing the first onset of migraine symptoms. The drug is packaged in individual pre-measured doses, with the dose sent into the nose then absorbed through the olfactory sensory nerves into the brain.

Pain relief for some participants within 15 minutes

The late-stage clinical trial enrolled 1,405 adult participants at 94 locations in the U.S. with a one-year history of migraines. Participants were randomly assigned to receive zavegepant or a placebo nasal spray as 10 milligram doses to use when first experiencing a migraine. The main outcome measure in the trial is a self-assessment of pain experienced within two hours after taking the drug, on a four-point scale from 0 for no pain to 3 for severe. Participants were also asked to indicate the presence or absence of other most bothersome non-pain symptoms including nausea and sensitivity to light and sound. Science & Enterprise reported on the beginning of the trial in April 2019.

Biohaven Pharma says more participants receiving zavegepant experience pain relief within two hours (24%) than placebo recipients (15%), a large enough difference for statistical reliability. Likewise, four in 10 zavegepant recipients (40%) say they are free of their most bothersome non-pain symptoms, compared to three in 10 placebo recipients (31%), also a statistically reliable difference. Of the trial participants reporting pain relief, 16 percent of zavegepant recipients say they’re pain free in 15 minutes, with another 30 percent within a half hour.

The company says more zavegepant than placebo participants report returning to normal functioning with 30 minutes, but does not give percentages. Biohaven Pharma says the most common adverse effect reported by more zavegepant than placebo participants is abnormal taste, 21 to 5 percent respectively, with most adverse effects rated as mild.

“The impressive efficacy, safety, and tolerability profile shown in this trial,” says Biohaven Pharma CEO Vlad Coric in a company statement, “highlights the potential of zavegepant to usher in a new era of non-oral CGRP targeting migraine therapies that may transcend the traditional boundaries of older legacy intranasal migraine approaches.” The company expects to file a new drug application with FDA in the first quarter of 2022.

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