The drug, Zavzpret, also known as zavegepant, was approved on Thursday for the treatment of acute migraines with or without an aura in adults.
“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Pfizer’s Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business.
The FDA’s greenlight hinged on late-stage study data, which showed Zavzpret was more effective than the placebo in 13 of 17 test categories, including providing pain relief in 15 minutes and restoring normal function at around half an hour. Among the 1,405 people who participated in the trial between October 2020 and August 2021, about 24% of those who took the drug said they experienced pain freedom two hours after treatment compared to 15% of people in the placebo group.
“When a migraine hits, it has a significant negative impact on a person’s daily life,” said Kathleen Mullin, M.D., Associate Medical Director at New England Institute for Neurology & Headache. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works.”
A migraine is defined as a series of at least five headache attacks lasting between four and 72 hours, according to the National Headache Foundation. They can cause severe throbbing pain or a pulsing sensation in the head, with other symptoms often including nausea, vomiting, or sensitivity to light and sound.
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