Pfizer's zavzpret nasal spray gains approval for treatment of migraine

Pfizer makes a breakthrough in migraine treatment with the approval from the US FDA of its new drug Zavzpret™ (zavegepant) in the form of a nasal spray, which adds to their current portfolio of oral migraine prevention and treatment therapies. 

The nasal spray was tested in a Phase III clinical trial on patients with migraines with or without auras, and compared to a placebo. The primary end points of the study were taken as freedom from pain and freedom from most bothersome symptoms when measured 2 hours after the provision of the dose. According to monitoring for a secondary end point, pain relief was logged even as quickly as 15 minutes after dosing. 

“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,” explained Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “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 will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”

The nasal spray has been rigorously tested in randomized, double-blind, placebo-controlled trials to determine the efficacy, tolerability and safety of zavzpret. In all of these studies, zavzpret demonstrated significantly better outcomes than when compared to a placebo. In the most recent Phase III trial, the results of which were published in The Lancet Neurology, zavzpret showed significantly greater efficacy than the placebo in 13 out of 17 predetermined secondary endpoints. These included time to pian relief and time to normal function as 15–30 minutes and 30 minutes respectively. Other end points also measured were sustained pain freedom and relief after 2–24 hours and 2–48 hours. 

“When a migraine hits, it has a significant negative impact on a person’s daily life,” commented Kathleen Mullin, Associate Medical Director at New England Institute for Neurology & Headache. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. As a nasal spray with rapid drug absorption, zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

The safety of the nasal spray was tested, and minor adverse reactions were observed. The most common of which, – taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort, and vomiting – were seen in around 2% of patients. Hypersensitivity reactions have also occurred in trials involving zavzpret. 

The results were analysed by the US FDA and the spray was deemed worthy of approval. Pfizer hopes zavzpret will be available to patients from pharmacies by July 2023.