Monday, March 13, 2023

FDA approves nasal spray for migraine in adults

You'll have to ask your doctor if treating migraines after the fact is enough to reduce the risk of stroke to zero or does your doctor have to prevent the migraines from occurring. 

Migraine with aura – but not without – increases risk of stroke  Sept. 2017

link between migraine and stroke

Later Onset of Migraine With Aura Linked to Higher Stroke Risk

 

The latest here:

FDA approves nasal spray for migraine in adults

The FDA has approved Pfizer’s Zavzpret, a calcitonin gene-related peptide receptor antagonist nasal spray to treat migraine with or without aura in adults.

According to a company press release, approval was based on results of two randomized, double-blind, placebo-controlled studies that established the safety, efficacy and tolerability profiles of the intranasal therapeutic. In these studies, Zavzpret (zavegepant) was superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at 2 hours post-dose. The drug also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint compared with placebo.

Source: Adobe Stock.
The FDA has approved Pfizer’s novel nasal spray to treat migraine in adults. Image: Adobe Stock

“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, MBA, chief commercial officer and president of global biopharmaceuticals business at Pfizer, stated in the release.

Zavzpret was well-tolerated in these trials, per the release, with the most common adverse reactions of taste disorders, nausea, nasal discomfort and vomiting reported in at least 2% of trial participants. Hypersensitivity reactions, including facial swelling and urticaria, have also been reported.

According to Pfizer, Zavzpret is expected to be available in pharmacies in July 2023.

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