Scolr Pharma reports positive results from Phase III pain study

The trial incorporated FDA special protocol assessment design elements, met both co-primary endpoints (p<0.0001), and had no significant adverse events. In the current pivotal Phase III efficacy study performed at a single center in the US, of the 306 patients screened, 256 patients received study medication. This randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg release (ER) in dental pain following third molar extraction. The first primary endpoint was to demonstrate analgesic efficacy for the eight to 12 hour period after the first dose of Scolr's ER ibuprofen as compared to placebo. The second primary endpoint measured the durability of effect of Scolr's formulation by the proportion of subjects in the ibuprofen ER group with meaningful improvement in pain intensity from baseline at all three assessment periods of 24, 36, and 48 hours. Both endpoints achieved positive, statistically significant results, at the p<0.0001 level. Stephen Turner, chief technical officer of Scolr Pharma, said: "We are extremely pleased with these critically important results. In addition to the primary outcomes, we also achieved important secondary endpoints, including confirmed single dose onset of pain relief within one hour of the first dose, and then maintained efficacy over the full twelve hours following the patients' dental surgery." "We look forward to sharing the full results and analyses of this study at future business and scientific meetings as we receive the final clinical study report from our contract research organization, AAIPharma, in early 2009."