Topline
A new nasal spray could soon offer Americans “fast-acting relief” from migraines and launch a new form of medicine onto the market, Pfizer announced on Thursday, touting promising results from late stage testing as the Food and Drug Administration finishes evaluating the “breakthrough” drug.
The FDA is reviewing a nasal spray to treat migraine from Pfizer.
Key Facts
Pfizer said the study, which has been peer reviewed and published in the Lancet Neurology medical journal, showed its migraine drug zavegepant is “effective in the acute treatment of migraine.”
The trial assessed the drug’s ability to tackle pain and other migraine symptoms in 1,405 people who experience multiple migraine attacks a month, which they performed at 90 clinics and medical centers across the U.S., with half of participants receiving a single dose of the drug by nasal spray and the other half receiving a placebo.
Zavegepant was more effective than placebo for relieving pain when assessed two hours after dosing, Pfizer said.
Zavegepant also bested placebo at tackling patients’ “most bothersome symptom” after two hours, Pfizer said, referring to a key metric the Food and Drug Administration suggests researchers use in addition to addressing pain when testing migraine treatments that often covers symptoms including nausea and sensitivity to light or sound.
The nasal spray also performed better than placebo on a number of other tests, including pain relief beginning as soon as 15 minutes after dosing and sustained relief from two through 48 hours after treatment.
Pfizer said the drug was well tolerated and no serious side effects were identified in the trial, with the most common being an altered sense of taste, nasal discomfort and nausea.
Pfizer said the drug was well tolerated and no serious side effects were identified in the trial, with the most common being an altered sense of taste, nasal discomfort and nausea.
Key Background
Migraines are a common and often debilitating condition. Though severe headaches are a key characteristic of migraine, attacks are a complex phenomenon that can feature a litany of other symptoms including nausea, sensitivity to light and sound and visual disturbances, known as auras. Though precise figures are difficult to come by, estimates suggest as many as 1 in 10 people experience migraine and it regularly ranks among the leading causes of disability worldwide. The condition has a disproportionate effect on women. Despite the significant human and economic toll, there remain many unknowns, research funding is limited and it is frequently misdiagnosed. Treatments have historically been limited and associated with potentially significant side effects, though a number of breakthrough medications and devices in recent years have gone a long way in broadening options available to patients.
What To Watch For
Biohaven, a firm Pfizer acquired for approximately $11.6 billion last year, asked the FDA to review zavegepant nasal spray as a treatment for acute migraine in adults last May. The agency is expected to finish its review by the end of March. If approved, it will be the first and only drug of its kind to reach the market, something that will give it an edge over competitors in the $4.6 billion a year global migraine drug market, according to data and analytics firm GlobalData. James Rusnak, senior vice president and chief development officer at Pfizer, said the drug “has the potential to be a significant new treatment option for people with migraine, particularly those who desire fast-acting relief or would benefit from an alternative delivery method.” The results give hope the company will soon be “bringing a new medical breakthrough to millions of people suffering from migraine in the U.S.,” Rusnak added.
Big Number
40 million. That’s how many Americans have migraine, according to the National Headache Foundation, more than 1 in every 10 people. The majority of sufferers are women, who make up 70% of cases, and nearly a quarter of those living with the condition report having had symptoms so severe they sought emergency room care.