FDA approval decision date for Pozen's(POZN) pain drug Vimovo.
Reasons why we believe Vimovo will be approved on April 30, 2010:
1. Esomeprazole (approved in a delayed release form as Nexium) is already approved for combination use with naproxen (an approved OTC drug at lower doses).
2. Phase III program met primary endpoint and was conducted under a special protocol assessment (SPA).
3. Significant unmet medical need for patients given the withdrawal of Vioxx and Bextra.
4. ACC & ACG both recommend gastro-protectant for patients taking daily NSAIDs.
5. FDA compared benchmark NSAID safety to naproxen back during the Cox-II issues in 2005. Vioxx was removed from the market and many on the FDA felt as though naproxen + PPI was a safer alternative.