In a double-blind, randomised, phase 3 trial, zavegepant 10 mg nasal spray was more effective than placebo for the acute treatment of migraine. It provided a rapid onset of pain relief as early as 15 minutes post-dose, sustained benefits to 48 hours post-dose, and showed favourable safety and tolerability.
In the acute treatment of migraine, non-oral therapies are recommended for attacks that include severe nausea or vomiting, or rapidly escalating headaches. Zavegepant is the only small-molecule calcitonin gene-related peptide (CGRP) antagonist delivered by nasal spray for the acute treatment of migraine. Dr Robert Croop (Biohaven Pharmaceuticals, USA) presented the results of the double-blind, randomised study (NCT04571060) that assessed the efficacy and safety tolerability of zavegepant nasal spray.
Participants were 18 years or older, with at least a 1-year history of migraine and 2–8 moderate-to-severe migraine attacks during >15 monthly headache days in the 3 months prior to screening. Of the 1,405 randomised participants, 1,269 were evaluated for efficacy (zavegepant n=623; placebo n=646). The mean age was 41 years, 83% were women. The participants self-administered 1 dose of zavegepant 10 mg nasal spray or placebo to treat 1 migraine attack of moderate-or-severe pain intensity. There were 2 primary endpoints: 2-hour freedom from pain and the most bothersome symptom (MBS).
Zavegepant was superior to placebo for 2-hour freedom from pain (23.6% versus 14.9%, p<0.0001) and 2-hour freedom from MBS (39.6% vs 31.1%; P=0.0012). The active treatment was also superior to placebo on multiple secondary endpoints, including:
- pain relief at 15 minutes (15.9% vs 8.0%; P<0.0001);
- pain relief at 2 hours (58.7% vs 49.7%; P=0.0012);
- return to normal function at 30 minutes (10.5% vs 6.1%; P=0.0059);
- return to normal function at 2 hours (35.8% vs 25.6%; P=0.0001);
- sustained pain relief 2 to 48 hours post-dose (36.1% vs 29.6%; P=0.013).
No serious adverse events were observed; most were mild or moderate. The most common adverse events, occurring in ≥2%, were dysgeusia (20.5% vs 4.7%, respectively), nasal discomfort (3.7% vs 0.8%), and nausea (3.2% vs 1.1%).
- Croop R. Efficacy and safety of zavegepant nasal spray for the acute treatment of migraine: Results of a phase 3 double-blind, randomized, placebo-controlled trial. P136a, EHC 2022, 07–10 December, Vienna, Austria.
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