US FDA approves Pfizer's fast-acting nasal spray for migraine
The U.S. Food and Drug Administration (FDA) has approved a fast-acting nasal spray from Pfizer Inc. for migraine treatment, according to a press release published on March 10 by the company.
Named ZAVZPRET, the drug was approved for acute migraine treatment and is expected to be available in pharmacies in July 2023.
"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," told Pfizer chief commercial officer Angela Hwang in the 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 will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease."
The drug was superior in 13 of 17 prespecified goals
The FDA has approved the drug based on two pivotal randomized, double-blind, placebo-controlled studies conducted to establish ZAVZPRET's performance in the acute treatment of migraines. The results eventually showed that ZAVZPRET outperformed the placebo on two critical measures - pain freedom and freedom from the most bothersome symptom, two hours after taking the medication.
The Phase 3 study has also shown that ZAVZPRET has a wide-ranging efficacy. It showed statistical superiority to placebo in 13 of 17 prespecified secondary outcome measures, such as early time point endpoints, returning to normal function at two hours, and durable efficacy endpoints. However, in the 14th outcome measure (return to normal function at 15 minutes post-dose), no significant difference was observed between ZAVZPRET and placebo.
"When a migraine hits, it has a significant negative impact on a person’s daily life," said Kathleen Mullin, M.D., 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."
Hypersensitivity reactions were reported
The most common side effects in patients treated with ZAVZPRET during the clinical trials were taste disorders (including dysgeusia and ageusia), nausea, nasal discomfort, and vomiting. These side effects were seen in at least two percent of patients and occurred more frequently than in patients who received a placebo.
Furthermore, it is also noted that ZAVZPRET cannot be used in patients with a known history of hypersensitivity to zavegepant or any of its components since hypersensitivity reactions, such as facial swelling and urticaria, have been reported in clinical studies.
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