Advantages in Adding Intranasal Zavagepant to the Migraine Treatment Landscape: Richard B. Lipton, MD

WATCH TIME: 5 minutes

"Overall, migraine therapy is not a one-size-fits-all circumstance, and the encouraging thing in this study is that there’s strong efficacy and safety to support a new rapidly acting nasal formulation of a gepant might soon become available for patients who need it and for doctors to prescribe."

The recent introduction of calcitonin gene-related peptide (CGRP) receptor antagonists has changed the way clinicians have cared for patients with migraine. Since the first CGRP was approved in 2019, the capabilities of these medications have thus expanded, most notably rimegepant (Nurtec ODT; Biohaven), which in 2021 became the first therapy to be approved for both acute and preventive use. Biohaven’s other CGRP agent, zavegepant, is currently under FDA review and, if approved, would become the first marketed intranasal medication to treat migraine.

At the 2022 American Headache Society (AHS) Annual Meeting, June 9-12, in Denver, Colorado, data from one of the pivotal phase 3 studies (NCT04571060) used in the new drug application submission was presented, with zavegepant once again proving efficacy as an acute medication. The trial included 1405 individuals with a history of 2 to 8 moderate or severe monthly migraine attacks who were randomized to either zavegepant 10-mg nasal spray or placebo to treat 1 migraine attack of moderate or severe pain intensity.

Results showed that zavegepant was superior to placebo for the coprimary end points, freedom from pain (23.6% vs 14.9%; P <.0001) and freedom from the most bothersome symptom (39.6% vs 31.1%; P = .0012) at 2 hours post dose.¹ To learn more about the results and how they further add to zavegepant’s overall clinical profile, NeurologyLive® sat down with Richard B. Lipton, MD, director, Montefiore Headache Center. With a PDUFA date set for Q1 2023, Lipton provided insight on the advantages zavegepant could bring to the migraine medication market, if approved, and why the nasal spray speaks to the progress made within the field.

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REFERENCE
1. Mullin K, Croop R, Pavlovic JM, et al. Efficacy and safety of zavegepant nasal spray for the acute treatment of migraine: results of a phase 3 double-blind, randomized, placebo controlled trial. Presented at: AHS Annual Meeting, 2022; June 9-12; Denver, CO. IOR-01