FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR 'Dual Opioid' Pain Therapy

FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR 'Dual Opioid'
Pain Therapy

No Long Term Safety Data Required; Only Two Additional Phase 3 Studies for NDA
Submission

SYDNEY, Australia and BEDMINSTER, N.J., Aug. 5 /PRNewswire-FirstCall/ --
QRxPharma Limited (ASX: QRX; OTCQX: QRXPY), a clinical-stage specialty
pharmaceutical company focused on the development and commercialization of
therapies for pain and central nervous system (CNS) disorders, announced today
that the U.S. Food and Drug Administration (FDA) accepted its proposed Phase 3
protocol designs and statistical analyses to demonstrate the efficacy and
safety of Q8003IR, an immediate release dual-opioid (morphine plus oxycodone)
product intended for the management of moderate to severe acute pain. Pending
incorporation of the FDA's recommended modifications, only two Phase 3 trials
will be required for NDA filing. Under this streamlined clinical development
program, no additional pharmacology, toxicology or long-term clinical safety
studies will be required for regulatory submission and market approval.

"This is a significant and positive outcome," said Dr. John Holaday, Managing
Director and Chief Executive Officer, QRxPharma, commenting on the FDA review
meeting. "Acceptance of QRxPharma's streamlined development plan for Q8003IR
is a measure of success in terms of reduced risk, resource efficiencies, and
potential value of dual opioids. We believe this outcome serves to reinforce
the soundness of our business strategy - to expand the clinical utility of
existing compounds and deliver new treatments for targeted indications with
well-defined paths to regulatory approval and sales."

Following QRxPharma's FDA meeting on July 21, 2008, the Company reported the
Agency had determined no new animal safety studies were needed, accepted the
design of the proposed combination rule study with minimal modifications, and
found the proposed number of patients receiving Q8003IR, as well as the
duration of dosing, sufficient for regulatory submission of a 505(b)2 NDA.

"No additional clinical studies or measures of safety and efficacy beyond
those proposed by QRxPharma were requested," said Dr. Warren Stern, Executive
Vice President, Drug Development, QRxPharma. "Having successfully completed
an initial Phase 3 trial in April2008, QRxPharma continues to satisfy FDA
requirements and demonstrate the potential of Q8003IR to provide equal or
better analgesia with a reduction of total opioid dose and improved
tolerability."

Final Phase 3 studies for Q8003IR will include a combination rule study in
patients experiencing post-surgery (bunionectomy) pain and placebo controlled
study in patients following total knee replacement.

Forward Looking Statements
This press release contains forward-looking statements. Forward-looking
statements are statements that are not historical facts; they include
statements about our beliefs and expectations. Any statement in this release
that states our intentions, beliefs, expectations or predictions (and the
assumptions underlying them) is a forward-looking statement. These statements
are based on plans, estimates and projections as they are currently available
to the management of QRxPharma. Forward-looking statements therefore speak
only as of the date they are made, and we undertake no obligation to update
publicly any of them in light of new information or future events.

By their very nature, forward-looking statements involve risks and
uncertainties. A number of important factors could therefore cause actual
results to differ materially from those contained in any forward-looking
statement. Such factors include risks relating to the stage of products under
development; uncertainties relating to clinical trials; dependence on third
parties; future capital needs; and risks relating to the commercialization of
the Company's proposed products.

About QRxPharma
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) 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 business strategy to expand the clinical utility and commercial
value of marketed and/or existing compounds, the Company's product portfolio
includes both late and early stage clinical drug candidates with well-defined
paths to regulatory approval and sales. QRxPharma intends to directly
commercialize its products in the US and seek strategic partnerships abroad.
QRxPharma's lead compound, Q8003IR, completed its first Phase 3 clinical trial
in April 2008, having met all primary and secondary endpoints. The Company's
preclinical and clinical pipeline includes other technologies in the fields of
pain management, neurodegenerative disease and venomics. For more
information: www.QRxPharma.com.

SOURCE QRxPharma Limited

Alicia Moran, +1-410-991-7027, Alicia@brightlinemedia.com, for QRxPharma
Limited