Newly Approved Migraine Nasal Spray Offers Alternative Treatment to Injections, Oral Medications: Shae Datta, MD

WATCH TIME: 5 minutes

“In summary, this adds hope to some of the 40 million patients in the United States who suffer from migraines, the second leading cause of disability. This approval will help us control migraines in patients better if they have injection phobia, don't want to take pills, or don't remember to take their pills or bring it with them.”

On March 10, 2023, the FDA approved zavegepant nasal spray, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults. The therapy, marketed as Zavzpret, is the first and only CGRP nasal spray available for patients with migraine, expected to be available to pharmacies starting in July 2023.¹ The nasal spray is a third-generation, high-affinity, selective and structurally unique agent that had its new drug application (NDA) backed by 2 pivotal double-blind, placebo-controlled studies.

In the first trial (NCT03872453), zavegepant 10- and 20-mg doses were more effective than placebo on the coprimary end points of pain freedom at 2 hours postdose (placebo: 15.5% [98.3% CI, 11.1, 19.8]; 10 mg: 22.5% [98.3% CI, 17.5, 27.6]; P = .0113; 20 mg: 23.1% [98.3% CI, 18.1, 28.2]; P = .0055) and freedom from the most bothersome symptom (MBS) at 2 hours postdose (placebo: 33.7% [98.3% CI, 28.0, 39.3]; 10 mg: 41.9% [98.3% CI, 36.0, 47.9]; P = .0155; 20 mg: 42.5% [98.3% CI, 36.6, 48.4]; P = .0094).² Then, in the second trial (NCT04571060), not only were the coprimary end points of pain freedom (24% vs 15%; P <.0001) and freedom from MBS (40% vs 31%; P = .0012) achieved, but the treatment showed statistically significant differences relative to placebo across a total of 15 prespecified primary and secondary outcome measures.³

Shae Datta, MD, neurologist and migraine expert from NYU Langone Health, sat down with NeurologyLive®to provide her clinical perspective on the approval and what it means for patients with migraines. In addition, Datta, who is codirector of the NYU Langone concussion center, talked about the supporting data from the trials and the significance of the findings.

REFERENCES
1. Pfizer’s Zavzpret (zavegepant) migraine nasal spray receives FDA approval. News release. Pfizer. March 10, 2023. Accessed March 17, 2023. https://www.businesswire.com/news/home/20230309005795/en/Pfizer%E2%80%99s-ZAVZPRET%E2%84%A2-zavegepant-Migraine-Nasal-Spray-Receives-FDA-Approval
2. Biohaven achieves positive topline results in pivotal phase 2/3 study of vazegepant, the first and only intranasal CGRP receptor antagonist in clinical development for the acute treatment of migraine. News release. December 17, 2019. Accessed March 17, 2023. https://www.prnewswire.com/news-releases/biohaven-achieves-positive-topline-results-in-pivotal-phase-23-study-of-vazegepant-the-first-and-only-intranasal-cgrp-receptor-antagonist-in-clinical-development-for-the-acute-treatment-of-migraine-300976000.html
3. 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, randomized, placebo-controlled multicentre trial. Lancet Neurol. 2023;22(3):209-217. doi:10.1016/S1474-4422(22)00517-8