Zavegepant nasal spray provides ultra-rapid relief of acute migraine
NEW YORK 18/06 - A single dose of zavegepant nasal spray provided relief of acute migraine pain in as little as 15 minutes, with sustained relief through 48 hours, according to a clinical trial.
"We always consider nasal sprays to be faster than oral medications because of the route of administration but to hit that 15 minute mark is really impressive. It's rare that an oral medicine would be that effective that quickly," Dr. Kathleen Mullin of the New England Institute for Neurology and Headache in Stamford, Connecticut, told Reuters Health by phone.
She presented the data at the American Headache Society Annual Meeting in Denver, Colorado.
Zavegepant is being developed by Biohaven Pharmaceuticals, which funded the study. Zavegepant is the only small-molecule CGRP-receptor antagonist delivered by nasal spray in late-stage development for acute treatment of migraine.
The efficacy and safety of zavegepant 10 mg nasal spray was tested in a double-blind, phase-3 placebo-controlled trial in 1,269 adults with two to eight migraine attacks of moderate or severe intensity and more than 15 headache days over the past three months.
Patients treated a single migraine attack of moderate to severe intensity with either zavegepant nasal spray or placebo spray.
Zavegepant was superior to placebo for the coprimary endpoints of freedom from pain two hours after dosing (23.6% vs. 14.9%, P<0.0001) and freedom from most bothersome symptom two hours post-dose (39.6% vs. 31.1%, P=0.0012), Dr. Mullin reported.
Zavegepant nasal spray worked fast, with 15.9% of patients reporting onset of pain relief as early as 15 minutes after dosing compared with 8.0% of placebo patients (P<0.0001).
More patients in the zavegepant group also had pain relief at two hours (58.7% vs. 49.7%, P=0.0012); return to normal function at 30 minutes (10.5% vs. 6.1%, P=0.0059) and two hours (35.8% vs. 25.6%, P=0.0001); and sustained pain relief two to 48 hours after dosing (36.1% vs. 29.6%, P=0.013).
The most common adverse events with zavegepant were dysgeusia (20.5% vs. 4.7% with placebo), nasal discomfort (3.7% vs. 0.8%) and nausea (3.2% vs. 1.1%). Most AEs were mild or moderate; none was serious and there was no signal of liver toxicity.
"Having an effective nasal spray for acute migraine treatment is really exciting for us in the headache community, especially in this novel CGRP-receptor-antagonist science," Dr. Mullin told Reuters Health.
The U.S. Food and Drug Administration (FDA) has accepted Biohaven's new drug application for zavegepant nasal spray for the acute treatment of migraine in adults (https://bit.ly/3HtLjiV).
Dr. Mullin disclosed financial relationships with Biohaven.