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(Adds CEO comments, analyst's sales estimate)
By Amruta Khandekar
Dec 6 (Reuters) - Biohaven Pharmaceutical's intranasal spray to treat migraine helped relieve pain in as early as 15 minutes and met the main goals in a late-stage study, paving the way for the company to file for approval in the United States next year.
The pain relief lasted for 48 hours in patients after a single intranasal dose of the drug, zavegepant, in the trial that involved 1,405 adults, the drugmaker said on Monday.
Biohaven already has an oral migraine drug, Nurtec ODT, which is approved in the U.S. for both treatment and prevention. It competes in a crowded migraine therapy market, which includes drugs like AbbVie's orally administered Ubrelvy, and Impel NeuroPharma's recently approved nasal spray, Trudhesa.
Nurtec is going to be the preferred medication for regular use as a first-line therapy, however zavegepant would play an important role in cases where people need quick relief, Biohaven Chief Executive Officer Vlad Coric told Reuters.
"We want them (patients) to be able to have multiple tools in their tool kits to fight migraine and customise their response," Coric added.
Around 39 million Americans suffer from migraine, according to the Migraine Research Foundation.
Biohaven said on Monday zavegepant was superior to placebo in relieving pain and most other "bothersome" symptoms, including nausea or sensitivity to light or sound, at two hours.
A mid-to-late stage trial of the drug, evaluating the same main goals, had shown similar results earlier.
"Although this is not a gamechanging product, we believe it will help maintain and potentially grow Biohaven's overall (migraine) franchise leadership," said Cowen analyst Ken Cacciatore.
William Blair analyst Tim Lugo expects zavegepant to bring in greater than $400 million in sales by 2025.
Pfizer Inc will acquire overseas marketing rights to zavegepant and rimegepant, branded as Nurtec ODT, from Biohaven, the companies said last month. (Reporting by Amruta Khandekar; Editing by Vinay Dwivedi and Amy Caren Daniel and Shailesh Kuber)