This placebo controlled, double blind safety extension trial is designed to collect longer-term use patient safety data in support of the company’s submission of a new drug application to the FDA for the use of Q8003IR in the management of moderate to severe pain.
For this Phase III safety extension trial, patients actively enrolled in the post-surgical bunionectomy trial have the option to continue receiving doses of Q8003IR to control pain for up to 28 additional days. The primary end point of this safety extension trial is to evaluate the overall safety and side effect profile of Q8003IR when used for up to 28 days of treatment, followed by a withdrawal period of up to three weeks during which dosing with Q8003IR is gradually reduced.
Q8003IR is a patent-protected combination of two well-known drugs, morphine and oxycodone, that have been shown to provide synergistic effects on pain relief with a significant reduction of total opioid dose and side effects.
John Holaday, managing director and CEO of QRxPharma, said: “The initiation of QRxPharma’s second Phase III study is part of our planned series of clinical trials leading to submission of our NDA for Q8003IR in 2009, with product launch anticipated in 2010.”