Zavegepant nasal spray was effective for acute migraine, demonstrating onset of efficacy as early as 15 minutes post-dose and a favorable safety profile.
Non-oral acute therapies for migraine are recommended when oral forms are associated with inadequate response, slow onset of action, or poor tolerability. Rapid-onset effect is a priority for many patients with migraine, said Richard Lipton, MD, who presented the study results. He added that most patients with migraine prefer nasal sprays to injectables. Zavegepant is the only small molecule CGRP receptor antagonist delivered by nasal spray in late-stage development for the acute treatment of migraine. Its effects and safety were compared to placebo in a phase 3, double-blind, randomized trial.
Participants were adults who typically had 2-8 moderate or severe monthly migraine attacks. They self-administered one dose of zavegepant 10 mg nasal spray or a matching placebo to treat one migraine attack. The coprimary efficacy endpoints were freedom from pain and freedom from the most bothersome symptom (MBS) 2 hours after the intervention.
Participants had a mean age of 41; 83% were female. The MBS was photophobia in 60.4% of participants, nausea in 24.7%, and phonophobia in 15.0%.
In total, 1,269 participants were evaluable for efficacy. Dr. Lipton said that zavegepant nasal spray provided pain relief in as early as 15 minutes post-dose compared with placebo (15.9% vs 8.0%; P<0.0001). Within 2 hours of administration, significantly more patients achieved freedom from pain with zavegepant (23.6% vs 14.9%; P<0.0001). Zavegepant was also superior to placebo in 13 prespecified secondary endpoints, including freedom from MBS after 2 hours (39.6% vs 31.1%; P=0.0012); return to normal function after 2 hours (35.8% vs 25.6%; P=0.0001); and sustained pain relief 2 to 48 hours post-dose (36.1% vs 29.6%; P=0.013).
Most adverse events were mild or moderate; none were serious. The most common adverse events were dysgeusia (20.5% vs 4.7%), nasal discomfort (3.7% vs 0.8%), and nausea (3.2% vs 1.1%). There was no signal of hepatoxicity. Additional trials are needed to establish the long-term safety and consistency of effect across attacks.
“It is exciting to now have a non-oral option for patients with migraine who benefit from the class of CGRP receptor antagonists,” Dr. Lipton said.
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