Pfizer migraine nasal spray approved by U.S. FDA

The U.S. Food and Drug Administration on Friday approved Pfizer Inc’s migraine nasal spray, giving patients a potentially fast-acting pain relief option for headaches.

The drug Zavzpret, also known as zavegepant, has been approved for the treatment of acute migraine with or without aura in adults, the company said. An aura refers to any neurological disorder that appears shortly before or during the development of a migraine.

The drug, which will be priced at launch in July, is “expected to be priced comparable to other FDA-approved migraine medications” in the same drug class, the company told Reuters.

Pfizer added Zavzpret and other migraine treatments, including Nurtec ODT, to its drug portfolio when it bought Biohaven Pharmaceutical for $11.6 billion 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 hopes to gain a competitive advantage with Zavzpret’s fast-acting rate, and Biohaven has pitched it as a “migraine epipen.” Pfizer has projected peak sales of its migraine portfolio at $6 billion.

The approval was based on data from a late-stage study that showed the drug was superior to placebo in 13 of 17 endpoints, including pain relief at 15 minutes, normal function at 30 minutes and return to normal at 2. hours

The drug, when compared with placebo, failed to show a statistically significant difference in one of the secondary endpoints of return to normal function within 15 minutes.

The drug’s label includes a warning advising patients to stop taking it if they experience hypersensitivity reactions such as facial swelling and skin rash after use.

Migraines affect 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