New Nasal Spray for Migraines Approved by FDA
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.
About 40% of the trial participants who took the medication were free of their worst symptoms two hours after using the medication. About 40% reported improvement compared to about 31% of those on a placebo.
About 20% of those who took the medication experienced an altered sense of taste. Nasal discomfort and nausea were other reported side effects.
Zavzpret blocks the release of calcitonin gene-related peptides, a type of protein. Past research has found these proteins are increased during a migraine, the Times reported.
“And I think that discovery has been really groundbreaking in helping us to better understand what happens when someone is having a migraine attack,” Dr. Rashmi Halker Singh, an associate professor of neurology at the Mayo Clinic, told the Times.
Other available nasal products use a drug that targets serotonin receptors using triptans, the Times reported. However, those drugs are not indicated for people at risk of heart attack or stroke.
Nasal sprays can be absorbed more quickly than pills. Migraine sufferers also often have nausea.
“Hopefully this will help us help more people,” Halker Singh said. “That's the bottom line, right?”
The National Institute of Neurological Disorders and Stroke has more on migraine.
SOURCE: New York Times