Safety extension study to be part of NDA submission in 2009
SYDNEY, Australia, Dec. 13 /PRNewswire/ -- QRxPharma (ASX: QRX) announced today the initiation of a second Phase III clinical trial for its lead product candidate Q8003IR, an immediate release dual-opioid pain therapy. 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 (NDA) to the US Food and Drug Administration (FDA) for the use of Q8003IR in the management of moderate to severe pain.
"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," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "This safety extension study follows the commencement of the Company's first Phase III study for acute post-surgical pain announced on November 26, 2007."
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. Given the availability of this patient population, QRxPharma has elected to start this safety extension trial at this time, which corresponds with the timeline outlined in the Company's Prospectus. The precise number of patients needed, the dose levels achieved, and the duration of treatment required to complete the full longer-term use safety database for Q8003IR will be determined with the FDA. 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 3 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.
QRxPharma (ASX: QRX) is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management and central nervous system (CNS) disorders. Based on a focused business strategy to expand the clinical utility and commercial value of marketed compounds, the Company's product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk of failure, abbreviated development paths, and improved patient outcomes. The Company intends to directly commercialize its products in the US and seek strategic partnerships abroad. QRxPharma's lead compound, Q8003IR, began Phase III clinical trials in November 2007. The Company's preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. For more information: http://www.QRxPharma.com.