US FDA approves Pfizer's nasal spray for migraine
March 10 (Reuters) - The U.S. Food and Drug Administration on Friday approved Pfizer Inc's (PFE.N) nasal spray for migraine, 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 gained the drug as well as FDA-approved oral migraine pill Nurtec ODT, through its $11.6 billion buyout of Biohaven Pharmaceutical last year.
Pfizer has forecast peak sales from its migraine pipeline to be around $6 billion.
Zavzpret, to be launched in July, would be comparable in price to other FDA-approved migraine medicines that belong to the same class of drugs, Pfizer told Reuters.
The drug, also known as zavegepant, will be competing with rivals from AbbVie Inc , Eli Lilly and Co (LLY.N), Amgen Inc (AMGN.O) and Teva Pharmaceutical (TEVA.TA) that are also calcitonin gene-related peptide (CGRP) inhibitors.
"The (Pfizer) drug has two main advantages over the older CGRP antagonists: it is safe for people with cardiovascular risk factors, and second, it does not cause medication overuse headache," said Dr Emad Estemalik, psychiatrist at Cleveland Clinic.
A nasal spray would also benefit patients who are unable to swallow a pill, Estemalik said.
Pfizer is hoping to gain a competitive edge in the migraine drug category with Zavzpret, which Biohaven has called the "Epipen of migraine", for its quick action.
Zavzpret's approval was based on late-stage study data that showed the drug was superior in 13 of 17 goals when compared to placebo, including pain relief in 15 minutes and normal function at 30 minutes.
About 39 million people in the United States suffer from migraine, according to the Migraine Research Foundation.
Pfizer's shares were marginally up at $39.75 in noon trading.
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