Pfizer Reports P-III Trial Results of Zavegepant for the Acute Treatment of Migraine in Adults
Shots:
- The P-III trial evaluates zavegepant (10mg) vs PBO in a ratio (1:1) in 1405 patients. The study met its co-primary EPs i.e., zavegepant was more effective than PBO for pain freedom (24% vs 15%) & freedom from the most bothersome symptom (40% vs 31%) @2hr. post-dose
- Relief from migraine pain in 15min. with relief lasting ~48hr., treatment with zavegepant was associated with higher rates of return to normal functional ability at 30min. post-treatment & 2hrs. The results were published in The Lancet Neurology
- The therapy was well tolerated with no serious AEs & the safety profile was consistent with earlier studies with no signal of hepatotoxicity due to zavegepant. Intranasal zavegepant's NDA was submitted to the US FDA & an anticipated PDUFA for completion of the review in Q1’23
Ref: Pfizer | Image: Pfizer
Related News:- Biohaven Reports Results of Zavegepant in P-III Study for the Treatment of Migraine
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