Zavzpret is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, indicated for the acute treatment of migraine in adults, and is not recommended for use as a preventive treatment for migraine
Pfizer has received the US Food and Drug Administration (FDA) approval for Zavzpret (zavegepant) for the acute treatment of migraine with or without aura in adults.
Zavzpret is a third-generation, high affinity, selective and structurally unique, small molecule calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray
The drug is indicated for the acute treatment of migraine with or without aura in adults and is not recommended for use as a preventive treatment for migraine.
According to Pfizer, small molecule CGRP receptor antagonists work through a unique mode of action and provide an alternative to patients who cannot use triptans.
Also, CGRP signal-blocking therapies do not cause medication overuse headaches (MOH) or rebound headaches, which limits the clinical utility of other acute treatments.
Zavzpret is the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations, said the US drugmaker.
ZAVZPRET is anticipated to be available in pharmacies in July 2023.
Pfizer chief commercial officer and global biopharmaceuticals business president Angela Hwang said: “The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications.
“ZAVZPRET underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives.
“Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”
The US FDA approval is based on two randomised, double-blind, placebo-controlled studies, which established the efficacy, tolerability and safety profiles of Zavzpret in treating migraine.
In the clinical trials, the drug was statistically superior to the placebo in the co-primary endpoints, including a reduction in headache pain and, most bothersome symptoms within two hours.
The study also showed that Zavzpret resulted in pain relief as early as 15 minutes in a prespecified secondary endpoint, compared to a placebo.
In the Phase 3 study, Zavzpret showed statistically significant superiority to the placebo across 13 of 17 prespecified secondary outcome measures.
Zavzpret was well tolerated in clinical trials, with the most common adverse reactions including taste disorders, nausea, nasal discomfort and vomiting, said Pfizer.