Pfizer’s Fast-Acting Migraine Nasal Spray Takes Home US Approval

The US FDA has approved Pfizer’s Zavzpret (zavegepant) nasal spray for the acute treatment of migraine in adults. Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for this indication, the drugmaker said. 

The FDA approval adds to Pfizer’s list of approved treatments for acute migraine, including Nurtec (rimegepant). Zavzpret and Nurtec were the results of Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals in May 2022.   

Angela Hwang, Chief Commercial Officer of Pfizer, stated that Zavzpret’s approval marks a breakthrough for people with migraine who need freedom from pain and prefer something other than oral medications. 

“Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease,” said Hwang. 

Zavzpret is expected to be available in pharmacies in July 2023. 

Zavzpret Shown to Provide Greater Pain and Symptom Relief Versus Placebo

Positive data from two pivotal studies on Zavzpret formed the basis of the US approval. In these studies, Zavzpret was shown to be statistically superior to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache to no headache) and freedom from most bothersome symptoms at two hours post-dose. 

On other endpoints, Zavzpret-treated patients experienced quicker pain relief and returned to normal function compared to placebo. In addition, relief was also found to be long-lasting. The results of the pivotal studies were published in The Lancet Neurology. 

“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works,” said Kathleen Mullin, M.D., Associate Medical Director at New England Institute for Neurology & Headache.

“As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

In terms of safety, Zavzpret was well tolerated. The most common side effects observed during clinical trials of Zavzpret included taste disorders, nausea, nasal discomfort, and vomiting. The drug is not suitable for patients who are hypersensitive to it or its components. Hypersensitive reactions such as facial swelling and breakout of rashes have occurred with Zavzpret in clinical studies.

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Joy Lin

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