SYDNEY, Australia and BEDMINSTER, NJ, USA I May 27, 2014 I QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain. The Agency stated that there was not sufficient evidence to support approval of Moxduo at this time.  The Agency indicated clinical information demonstrating a clear benefit over oxycodone and morphine alone, either by efficacy, or safety, in an appropriate patient population, is needed.

The Company is presently reviewing the Agency’s feedback and will request a meeting with the FDA to clarify the steps required for approval.

“We will work with FDA to develop a clinical program that addresses the Agency’s feedback and ensure that the completed program will clearly demonstrate Moxduo’s benefit,” said Dr. Edward Rudnic, Chief Executive Officer, QRxPharma.

About QRxPharma
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new pain management and abuse prevention products. The Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risks and improved patient outcomes.QRxPharma has entered into strategic agreements with Actavis Inc., Paladin Labs Inc., Aspen Group and Teva Pharmaceuticals for the commercialisation of immediate release Moxduo in the US, Canada, Australia (including New Zealand and Oceania), South Africa and Israel. The Company’s clinical pipeline includes an intravenous (IV) and controlled release (CR) formulation of Moxduo. QRxPharma is also collaborating with Aesica Formulation Development Limited, for the worldwide promotion of QRxPharma’s proprietary Stealth Beadlets™ abuse deterrence technology. For more information, visit www.qrxpharma.com.

SOURCE: QRxPharma