Intranasal zavegepant is moderately superior to placebo for acute migraine in adults

Référence

Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: a phase 3, double-blind, randomised, placebo-controlled multicentre trial. Lancet Neurol 2023;22(3):209-217.

Sommaire

These researchers enrolled adults who had at least one year of migraines (2 - 8 attacks per month), with or without aura, with onset before 50 years of age. The participants randomly received either intranasal zavegepant (10 mg/dose; n = 629) or matching placebo (n = 653). The nasal sprays, delivered by single-dose delivery units, were to be used at the onset of a migraine. In addition to self-assessing their pain, each patient also was asked to identify their most bothersome symptom. In the event of sneezing or equipment malfunction, there was no redosing. The primary outcomes were being free from pain and free from the most bothersome symptom 2 hours after treatment. Patients chose their most bothersome symptom from a list: nausea, phonophobia, or photophobia. After 2 hours, more zavegepant-treated participants than placebo-treated participants were pain free (23.8% vs 14.9%; number needed to treat [NNT] = 12; 95% CI 8 - 23). Similarly, more zavegepant-treated than placebo-treated participants were free of their most bothersome symptom (39.7% vs 31.1%; NNT = 12; 8 - 31). Another important outcome, rescue medication used, was less frequent in the zavegepant group than in the placebo group (64% vs 70%; NNT = 17; 10 - 110). Adverse events, mostly in the form of dysgeusia, occurred more frequently in zavegepant-treated participants (30% vs 16%), though no participants experienced serious events and none discontinued treatment due to adverse events. On March 10, 2023, the US Food and Drug Administration approved zavegepant and it will likely be available in a few months under the trade name Zavzepret. Pricing information is not currently available, but I expect it to be much more expensive than intranasal triptans.