New Nasal Spray for Migraines Approved by FDA
MONDAY, March 13, 2023 (HealthDay News) – Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke.
The U.S. Food and Drug Administration has approved Pfizer Inc.'s zavegepant (Zavzpret), a 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's 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 didn't release pricing information.
"We've been waiting for this medication to come out," Dr. Timothy Collins, chief of the headache division at Duke University Medical Center's neurology department, told the New York Times. "It's a really helpful addition to migraine management."
The FDA approval was based largely on the results of a clinical trial published this month in the journal 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% of those who took the medication. About 15% of those who took a placebo also reported freedom from pain.