FDA approves Pfizer’s (PFE) migraine nasal spray
By Sam Boughedda
Pfizer (NYSE:PFE) shares edged higher despite the overall dip in equities in the early part of Friday’s session after it announced the U.S. Food and Drug Administration (FDA) has approved its migraine nasal spray.
ZAVZPRET was shown to be “statistically superior” to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours post-dose in Pfizer’s Phase 3 study.
The company said it also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint.
The FDA approval was based on two studies that demonstrated the efficacy, tolerability, and safety profiles of ZAVZPRET. The company said it was well-tolerated in clinical trials, with the most common adverse reactions reported in at least 2% of patients being taste disorders, nausea, nasal discomfort, and vomiting.
“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,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.
Pfizer shares are up 0.5% at the time of writing.