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Zavegepant nasal spray exhibits good efficacy and safety in acute migraine

Presented By
Prof. Richard Lipton, Albert Einstein College of Medicine, USA
AAN 2023
Phase 3

Zavegepant 10 mg nasal spray was effective for the acute treatment of migraine, demonstrating onset of efficacy as early as 15 minutes post-dose, and sustained benefit. It had a favourable safety and tolerability profile: most adverse events were mild or moderate, none were serious.

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 Prof. Richard Lipton (Albert Einstein College of Medicine, NY, USA), who presented the study results [1]. He added that most migraine patients 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, randomised trial (NCT04571060). Participants were adults who had typically 2-8 moderate or severe monthly migraine attacks. They self-administered 1 dose of zavegepant 10 mg nasal spray or a matching placebo to treat 1 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 years; 83% were female. The MBS was photophobia in 60.4%, nausea in 24.7%, and phonophobia in 15.0% and 1269 participants evaluable for efficacy. Prof. Lipton said that zavegepant nasal spray provided pain relief as early as 15 minutes post-dose (15.9% vs 8.0%; P<0.0001). Within 2 hours of administration, significantly more patients achieved freedom from pain (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. In conclusion, Prof. Lipton said: “It is exciting to now have a non-oral option for migraine patients who benefit from the class of CGRP receptor antagonists.”

    1. Mullin K. Efficacy and safety of zavegepant nasal spray for the acute treatment of migraine: Results of a Phase 3 double-blind, randomized, placebo controlled trial. PL5.002, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.

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