The Food and Drug Administration on Friday approved Pfizer’s nasal spray for migraines, giving patients access to a potentially faster-acting pain relief option.
The company said the drug, Zavzpret, also known as Zavegepant, was approved to treat acute migraine with or without aura in adults. Aura refers to any neurological disturbance that appears shortly before or during the development of a migraine.
Pfizer acquired the drug, as well as the FDA-approved oral migraine pill Nartec ODT, through an $11.6 billion buyout of BioHaven Pharmaceuticals last year.
Pfizer told Reuters the drug, whose price will be revealed when it launches in July, is “expected to be comparable in price to other FDA-approved migraine drugs”.
Zavzpret belongs to a class of drugs called calcitonin gene-related peptide inhibitors and will compete with other treatments from AbbVie, Eli Lilly, Amgen and Teva Pharmaceutical.
Pfizer is hoping to gain a competitive edge with Zavzpret’s quicker speed of action, and Biohaven is touting it as the “EpiPen of migraines.”
The new drug isn’t the first nasal spray for migraines, although Cleveland Clinic headache specialist Dr. Emad Estemalik, said the quick, 15-minute relief gives the drug an advantage over existing oral treatments.
“A lot of patients, when they have a migraine, for example, they’re vomiting, so they may not be able to take oral medication,” he said. “That’s where an intranasal comes in as an advantage.”
Dr. Rashmi Halkar Singh of the Mayo Clinic in Phoenix had a similar opinion.
“Migraine is more than a headache,” the neurologist said in an interview.
He said people with migraines often have a variety of other symptoms, such as light sensitivity and nausea, and may benefit from a drug that isn’t a pill.
Halkar Singh, who is also on the board of the American Headache Society, is upbeat about the new drug, though she notes that about 20% of patients in clinical trials experienced altered taste compared to about 4.7% of patients who did not. felt the emotion. A placebo was given.
The FDA’s approval is based on late-stage study data showing that the drug, compared to placebo, proved superior in 13 of 17 goals, including pain relief in 15 minutes, normal function in 30 minutes, and two But normal return is included. hours.
The drug, when compared to a placebo, failed to show a statistically significant difference in one of the secondary goals of return 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 rashes.
According to the Migraine Research Foundation, migraines affect 39 million people in the United States.
