Positive outcome for Pozen's PA 325 PoC study

North Carolina, USA- based Pozen has announced positive top-line results of its "Safer Aspirin" PA 325 proof-of-concept study conducted during the fourth quarter of 2006. PA 325 is a patented formulation of 325mg of aspirin surrounded by a 20mg coating of an immediate-release formulation of a proton pump inhibitor.

The 28-day study involved two groups of 40 subjects over the age of 50. Each person was treated with either once-a-day commercially-available, enteric-coated aspirin 325mg or PA 325. The primary endpoint was gastrointestinal damage as measured by the Lanza scoring system used in previous Pozen studies. The results were highly significant, with 10% of the PA group having Lanza 3% or 4% gastrointestinal damage, whereas 57.5% of the enteric coated aspirin group had this level. Furthermore, no ulcers were seen in the PA group, while 20% of subjects in the enteric-coated aspirin 325mg arm developed a gastric ulcer during the study. This difference was also statistically significant.

John Plachetka, chief executive, stated: "the data from this first clinical study with PA 325 is very encouraging."