FDAnews
www.fdanews.com/articles/86284-pozen-moves-forward-with-pn-200-trials

POZEN MOVES FORWARD WITH PN 200 TRIALS

April 24, 2006

Pozen has completed a special protocol assessment (SPA) and reached agreement with the FDA on the design of its pivotal trials for PN 200. PN 200 is a product candidate for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric ulcers.

PN 200 is a combination of an acid inhibitor with a NSAID in a single tablet. The product is intended to manage pain and inflammation with fewer gastrointestinal side effects and less gastric damage, including ulcers, compared to an NSAID taken alone.