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Pfizer’s nasal spray for treating migraine gets FDA nod

US pharma multinational Pfizer has recently announced that the United States Food and Drug Administration has approved its calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant, marketed as Zavzpret nasal spray for the acute treatment of migraine in adults.

In a statement, the company informed that the approval follows two randomised clinical trials demonstrating that the drug significantly alleviated the symptoms and reduced pain within 15 minutes after administration.

“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,” Angela Hwang, Chief Commercial Officer, President of Global Biopharmaceuticals Business at Pfizer, said.

Pfizer said that it will continue to build its migraine franchise to support migraine patients worldwide further.

It may be recalled that according to a study published in The Journal of Headache and Pain, migraine is prevalent among 14% of the global population, and the researchers noted that cases of migraines are increasing across the globe. 

However, according to the FDA approval letter, the drug is only approved to treat adults.

In its communication to Pfizer, FDA said that it is waiving the paediatric studies requirement for children 0 to 5 years of age because necessary studies are impossible or highly impracticable.

“This waiver is being granted because very few children of this age can be definitively diagnosed with migraine,” the letter read.

The FDA further informed Pfizer that it is deferring the company’s submission for paediatric studies for children 6 to 17 years of age for this application because this product is ready for approval for use in adults and the paediatric studies have not been completed.

Commenting on the approval Dr Kathleen Mullin, Associate Medical Director at New England Institute for Neurology & Headache, said, “When a migraine hits, it has a significant negative impact on a person’s daily life.”

“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. 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,” she added.

According to Pfizer, the drug will be available in pharmacies throughout the United States by July 2023.

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