FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that the Phase IV CV outcomes PRECISION trial showed that Celebrex celecoxib from Pfizer Inc. (NYSE:PFE) had comparable cardiovascular safety to non-selective NSAIDS naproxen and ibuprofen.
Celebrex is an NSAID that selectively inhibits cyclooxygenase-2 (COX-2).
In 2004, Merck & Co. Inc. (NYSE:MRK) withdrew Vioxx rofecoxib, a COX-2-selective NSAID, from the market after a large randomized trial showed an increased risk of CV thromboembolic events. A 2005 FDA advisory committee opined that there appeared to be a class effect for CV risk associated with COX-2-selective NSAIDs, but there was less agreement regarding non-selective NSAIDs.
Pfizer conducted the long-term, prospective PRECISION trial to show that Celebrex was non-inferior to prescription strength doses of naproxen and ibuprofen on a CV safety composite endpoint when given to patients with chronic pain from osteoarthritis (OA) or rheumatoid arthritis.