The U.S. Food and Drug Administration on Friday approved Pfizer Inc's nasal spray for migraine, giving patients access to a potentially fast-acting pain-relief option for headaches.
The drug Zavzpret, also known as zavegepant, was approved for the treatment of acute migraine with or without aura in adults, the company said. Aura refers to any neurological disturbance that appears shortly before or during the development of migraines.
The drug, whose pricing will be revealed at launch in July, is "expected to be comparable in price to other FDA approved migraine medicines" which belong to the same class of drugs, the company told Reuters.
Pfizer added Zavzpret and other migraine treatments, including Nurtec ODT, to it drugs portfolio through its $11.6 billion buyout of Biohaven Pharmaceutical last year.
Zavzpret belongs to a class of drugs called calcitonin gene-related peptide inhibitors and will compete with other therapies from AbbVie Inc, Eli Lilly and Co, Amgen Inc and Teva Pharmaceutical.
Pfizer is hoping to gain a competitive edge with Zavzpret's quick speed of action, and Biohaven has pitched it as the "Epipen of migraine." Pfizer has forecast its migraine portfolio's peak sales at $6 billion.
The approval is based on data from a late-stage study that showed the drug, when compared to placebo, proved superior in 13 of the 17 goals, including pain relief in 15 minutes, normal function at 30 minutes, and return to normal at 2 hours.
The drug, when compared to placebo, failed to show statistically significant difference in one of the secondary goals of returning to normal function at 15 minutes.
The drug's label includes a warning advising patients to stop taking it in case of hypersensitivity reactions, such as facial swelling and skin rash after its use.
Migraine affects 39 million people in the United States, according to the Migraine Research Foundation.
Reporting by Khushi Mandowara and Bhanvi Satija in Bengaluru; Editing by Devika Syamnath, Anil D'Silva and Vinay Dwivedi
