For the immediate treatment of adult migraine with or without aura, ZAVZPRET (zavegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray to get FDA approval. Zavegepant Intranasal CGRP Antagonist Approved by FDA to Treat Acute It was statistically superior to placebo on the co-primary objectives of pain relief and freedom from the most bothersome symptom at two hours after dosage in its pivotal Phase 3 research.
ZAVZPRET’s FDA approval represents a significant advancement for migraine sufferers who require pain relief and favour non-oral treatment choices over oral drugs. Pfizer is dedicated to offering a second course of treatment so that people with migraines can find relief and resume their normal lives. “The US FDA has approved Pfizer’s Zavzpret nasal spray for migraines”
Two key randomised, double-blind, placebo-controlled studies that validated the drug’s effectiveness, tolerability, and safety profiles served as the foundation for the FDA’s approval of ZAVZPRET for the acute treatment of migraine. Two hours after the dose, the co-primary outcomes of freedom from the most bothersome symptom and freedom from pain freedom (defined as a reduction in moderate or severe headache pain to no headache pain) were statistically superior to placebo. In addition to showing broad efficacy, ZVZPRET also showed statistically significant superiority to placebo across 13 of 17 predetermined secondary outcome measures, according to the pivotal Phase 3 research that was published in The Lancet Neurology. Return to normal function 15 minutes after the treatment, the 14th goal, was insignificant. The rest of the auxiliary endpoints weren’t formally examined.
For migraine sufferers who require immediate pain relief or who are unable to take oral drugs owing to nausea or vomiting, Kathleen Mullin, M.D., Associate Medical Director at New England Institute for Neurology & Headache, suggests ZAVZPRET as an acute therapy alternative. Because the medication is absorbed fast through the nasal spray, they can quickly resume their daily activities.
In clinical trials, ZAVZPRET was well tolerated, with taste disturbances, nausea, nose pain, and vomiting being the most frequent side effects. “Zavzpret (zavegepant) Nasal Spray for the Acute Treatment Has Received FDA Approval,” It is expected to be available in pharmacies in July 2023 but is contraindicated in patients who have a history of hypersensitivity to zavegepant or any of its ingredients.