The double-blind, placebo-controlled study was designed to compare the efficacy and safety of four different dosage regimens of Q8003IR, a fixed ratio morphine/oxycodone combination.
Among all patients receiving Q8003IR, approximately 50% reported good to excellent global improvement (versus 13% for placebo) and demonstrated a strong dose-response effect (p<0.001) in reducing pain intensity scores [that is the sum of pain intensity difference over 48 hours relative to the first dose (SPID48)] and other measures of analgesic effect. Per treatment group, median doses received every four hours ranged from 3mg/2mg to 9mg/6mg of morphine/oxycodone. The data further demonstrate that Q8003IR was generally well tolerated, with a low rate of patient withdrawal (2% to 12% depending on dose versus 2% for placebo). In addition, there was minimal somnolence (2% to 8%) and changes to respiratory parameters (respiration rate, oxygen saturation) with no incidences of euphoria reported.