MONDAY, March 13, 2023 (HealthDay News) -- The U.S. Food and Drug Administration has approved Pfizer's zavegepant (Zavzpret), a calcitonin gene-related peptide receptor antagonist nasal spray meant to treat severe headache pain, the company announced Friday.
"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," Angela Hwang, chief commercial officer and president of Pfizer global biopharmaceuticals business, said in a company news release. "Zavzpret underscores Pfizer's commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives."
Pfizer expects the nasal spray to be in pharmacies by July, but it did not release pricing information.
The FDA approval was based largely on the results of a clinical trial published this month in The Lancet Neurology that found those who took the medication were more likely to return to normal within 30 minutes to two hours.
The medication worked for about 24 percent of those who took the medication. About 15 percent of those who took a placebo also reported freedom from pain. About 40 percent of the trial participants who took the medication were free of their worst symptoms two hours after using the medication. About 40 percent reported improvement compared with about 31 percent of those on a placebo.
About 20 percent of those who took the medication experienced an altered sense of taste. Nasal discomfort and nausea were other reported side effects.