QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study for MoxDuo(TM) IV Pa...( ...)

Efficacy and Safety Study in Patients with Moderate to Severe Post-Operative Pain

SYDNEY, Australia and BEDMINSTER, N.J., July 23 /PRNewswire-FirstCall/ -- QRxPharma Limited (Pink Sheets: QRXPY; ASX: QRX) announced today the initiation of a Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo(TM) IV (intravenous morphine and oxycodone) versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. Data from this study will serve as a significant predictor of MoxDuo(TM) IV's clinical benefits and provide guidance for the design of further clinical trials leading to submission of an NDA to the US Food and Drug Administration (FDA) within the next three years.

"QRxPharma's goal is to bring to market complementary analgesic options for pain specialists, delivering greater patient tolerability and efficacy than current standards of care. MoxDuo(TM) IV is one of three Dual-Opioid(TM) products that also include immediate-release (IR) and controlled release (CR) oral formulations," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.

QRxPharma's MoxDuo(TM) products are the only combination opioids in commercial development. Extensive clinical studies have shown Dual-Opioids(TM) to provide better pain relief with significantly fewer side effects.

This double blind, active controlled study will determine: (1) whether MoxDuo(TM) IV has fewer opioid-related adverse events than morphine alone at equianalgesic doses and (2) whether the maximum analgesic effect of MoxDuo(TM) IV is superior to morphine alone.

The study is being conducted at the Cologne-Merheim Medical Center, a part of Witten/Herdecke University, and Cologne University Hospital, both in Cologne, Germany.

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