Zavegepant is the only intranasal CGRP-receptor antagonist currently in late-stage clinical testing for the acute treatment of migraine. It's being developed by Biohaven Pharmaceuticals, which funded the study.
"Zavegepant is a third-generation, high-affinity, very selective and structurally unique compound that has high aqueous solubility and so it lends itself to an intranasal formulation and ultra-rapid delivery," Dr. Elyse Stock, Biohaven chief medical officer, noted in a phone interview with Reuters Health.
The study enrolled 1,581 adults (mean age, 41 years; 86% women) with a diagnosis of migraine for at least one year, two to eight migraine attacks of moderate or severe intensity and fewer than 15 monthly headache days over the last three months. About 14% of the study population was using preventive migraine medication. No use of CGRP monoclonal antibodies was permitted.
Participants in the study were randomly allocated to treat a single attack of moderate to severe migraine pain with zavegepant (5, 10 or 20 mg) or placebo.
Zavegepant 10-mg and 20-mg were superior to placebo on the co-primary endpoints of pain freedom at two hours post-dose and most bothersome symptom freedom at two hours post-dose, Dr. Robert Croop of Biohaven Pharmaceuticals reported at the American Headache Society virtual annual meeting.
At two hours, the rate of pain freedom was 15.5% in the placebo group, 22.5% in the 10-mg group (P=0.0113), and 23.1% in the 20-mg group (P=0.0055). The rate of pain freedom in the 5-mg group was not significantly different from that of the placebo group.
The rate of freedom from the most bothersome symptom at two hours was 33.7% in the placebo group, 41.9% in the 10-mg zavegepant group (P=0.0155), and 42.5% in the 20-mg group (P=0.0094). Again, the outcome with the 5-mg dose was not significantly different from that with placebo.
Intranasal zavegepant demonstrated "rapid onset" of pain relief, as early as 15 minutes after dosing, and "sustained pain freedom" was observed from two through 48 hours after dosing, Dr. Croop noted.
The most common adverse events were dysgeusia, nausea and nasal discomfort. Most adverse events were mild or moderate in intensity and not related to study drug. There was no signal of liver toxicity.
Based on the findings, a phase-3 clinical trial involving 1,400 patients has been initiated to evaluate intranasal zavegepant 10-mg versus placebo in the acute treatment of migraine.
SOURCE: https://bit.ly/3w78byx American Headache Society annual meeting, held June 3-6, 2021.
By Megan Brooks
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