US FDA approves Pfizer’s nasal spray for migraines

March 10 (Reuters) – The U.S. Food and Drug Administration on Friday approved Pfizer Inc’s ( PFE.N ) migraine nasal spray, giving patients access to a potentially fast-acting pain relief option for headaches.

The drug, Zavzpret, was approved for the treatment of acute migraine, the company said. Pfizer got the drug, as well as the FDA-approved oral migraine pill Nurtec ODT, through its $11.6 billion acquisition of Biohaven Pharmaceutical last year.

Pfizer has forecast topline sales from its migraine pipeline to be around $6 billion.

Zavzpret, due to launch in July, would be comparable in price to other FDA-approved migraine drugs belonging to the same class of drugs, Pfizer told Reuters.

The drug, also known as zavegepant, will compete with rivals from AbbVie Inc, Eli Lilly and Co ( LLY.N ), Amgen Inc ( AMGN.O ) and Teva Pharmaceutical ( TEVA.TA ), which also calcitonin gene-related peptide (CGRP ) inhibitors.

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“The Pfizer drug has two main advantages over the older CGRP antagonists: it’s safe for people with cardiovascular risk factors, and second, it doesn’t cause drug-overuse headaches,” said Dr. Emad Estemalik, a psychiatrist at the Cleveland Clinic.

A nasal spray would also benefit patients who are unable to swallow a pill, Estemalik said.

Pfizer hopes to gain a competitive advantage in the migraine drug category with Zavzpret, which Biohaven has dubbed the “Epipen of migraines,” for its rapid action.

Zavzpret’s approval was based on late-stage study data that showed the drug was superior in 13 of 17 measures compared to placebo, including pain relief at 15 minutes and normal function at 30 minutes.

About 39 million people in the United States suffer from migraines, according to the Migraine Research Foundation.

Pfizer shares rose marginally to $39.75 in midday trading.

Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru; Editing by Anil D’Silva, Vinay Dwivedi and Shinjini Ganguli

Our standards: Thomson Reuters Trust Principles.

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