New ‘Fast-Acting’ Migraine Drug Approved By FDA

Topline

The Food and Drug Administration on Friday approved a new nasal spray drug giant Pfizer says could offer “fast-acting relief” from migraines, launching a new form of medicine onto the market and expanding treatment options for the millions of people suffering from the common, often debilitating condition.

Migraines disproportionately affect women.

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Key Facts

The FDA approved the nasal spray, called zavegepant and branded as Zavzpret, for the acute treatment of migraine in adults.

Acute treatments are aimed at stopping or reducing symptoms once a migraine attack is already underway, which commonly include painful headaches, visual disturbances, nausea and sensitivity to light or sound.

Data from late-stage clinical trials published in February suggest zavegepant can provide fast pain relief in as little as 15 minutes—other treatments can take two hours to kick in—and helps tackle other bothersome symptoms.

Zavegepant—part of an emerging drug class called calcitonin gene-related peptide (CGRP) inhibitors—is the third migraine treatment of its kind to secure FDA approval and the first to be offered as a nasal spray.

This will be a boon to the many migraine sufferers who struggle to take oral medication on account of common symptoms like nausea and vomiting (the other FDA-approved CGRP treatments are available as tablets).

Angela Hwang, chief commercial officer and president of Pfizer’s global biopharmaceuticals business, said the approval “marks a significant breakthrough,” particularly for people who “need freedom from pain and prefer alternative options to oral medications.”

Key Background

Migraines are a common and often debilitating condition. While typically characterized by severe headaches, migraine attacks are a complex neurological phenomenon that can include a long list of symptoms including nausea, sensitivity to light and sound and visual disturbances, known as auras. Estimates suggest as many as 1 in 10 people experience migraine—disproportionately women—and it regularly ranks among the leading causes of disability worldwide. Though options to treat or prevent migraine attacks have been rather limited in the past, a bevy of new drugs have emerged in recent years, though headaches associated with overuse or after stopping—something not believed to happen with the CGRP drugs—have limited their utility. Pfizer will be hoping zavegepant lets it grab a slice of the migraine market, which data and analytics firm GlobalData estimate is worth $4.6 billion a year worldwide. It’s a market Pfizer is already familiar with and it has invested heavily in the area. Its drug rimegepant, sold as Nurtec ODT, is one of the other two CGRP migraine treatments approved by the FDA (it is also approved for preventing migraines). It gained both drugs after acquiring Biohaven for approximately $11.6 billion last year.

Big Number

40 million. That’s how many Americans suffer from migraines, according to the National Headache Foundation, more than 1 in every 10 people. Women make up 70% of cases. Nearly a quarter of the people living with the condition have reported having symptoms so severe they sought emergency room care in the past.

What To Watch For

Pfizer is testing an oral form of zavegepant to prevent migraines as well as treat them. The study, a mid-to-late stage clinical trial, is expected to finish in July. Pfizer’s Hwang said the company plans to “continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.” The company is also in the very early stages of investigating the drug as a potential treatment for asthma. Research suggests the system zavegepant targets is involved in the body’s inflammatory response as well as activating migraines. It is therefore possible it could prove useful for a condition like asthma, where inflammation restricts the airways.

What We Don’t Know

It’s not clear how much zavegepant will cost when it launches. A Pfizer spokesperson told Forbes the drug is expected to launch in July 2023 and its price is likely to be comparable to other FDA-approved CGRP migraine drugs on the market.