QRxPharma Limited (QRXPY)

[ErnieBilco]

FDA CONFIRMS REVIEW MEETING REGARDING MOXDUO®
NDA
Meeting on US 9 July to Address Steps Required for Approval of Moxduo

Sydney, Australia and Bedminster, New Jersey – QRxPharma Limited (ASX: QRX and
OTCQX: QRXPY) announced today that the United States Food and Drug Administration
(FDA) has confirmed that the “End of Review” meeting with management of the Company
will be held at 3:00pm (EDT) on 9 July 2014 in the United States to discuss the Company’s
Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain.
The FDA granted this meeting following the issue of a Complete Response Letter (CRL) last
month.
As detailed in the Company’s announcement to the ASX on 26 May 2014, the Agency stated
in the CRL 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.

###
Media Contact Information:
Lisa Fels Gavin Lower
Brightline Strategies Buchan Consulting
Tel: [phone] x110 Tel: [phone]
Email: [e-mail] Email: [e-mail]