FDA Sets 22 April 2014 For Moxduo® Advisory Committee Meeting

        FDA Sets 22 April 2014 For Moxduo® Advisory Committee Meeting

Committee to Review Respiratory Safety Data Comparing Moxduo with Components

PR Newswire

SYDNEY and BEDMINSTER, N.J., March 24, 2014

SYDNEY and BEDMINSTER, N.J., March 24, 2014 /PRNewswire-USNewswire/
--QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United
States Food and Drug Administration (FDA) has set 22 April 2014 as the date of
the Advisory Committee meeting to consider the Company's resubmitted Moxduo ^
New Drug Application (NDA).

"As previously announced, our PDUFA date is 25 May, 2014," said Dr. John
Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We look
forward to presenting to the Advisory Committee the Moxduo clinical data as
outlined in our New Drug Application highlighting what the Company believes is
Moxduo's respiratory benefit from Study 022."

The Advisory Committee meeting is open to the public and will be held from
8.00am to 5.00pm at the FDA White Oak Conference Center, in Building 31, the
"Great Room" (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland.
The meeting will also be webcast live, the details of which will be provided
by the FDA in advance of the meeting.

Additional information can be found on the FDA's website at:

 http://www.fda.gov/AdvisoryCommittees/default.htm

or by calling the FDA Advisory Committee Information Line:

 +1 800 741 8138 (301 443 0572 in the Washington,
DC area)

The Advisory Committee meeting is the next step in the Moxduo approval
process. Moxduo, an immediate release Dual Opioid^® therapy for the treatment
of moderate to severe acute pain, is a patented 3:2 fixed ratio combination of
morphine and oxycodone.

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. Based on a development strategy
that focuses on enhancing the clinical utility of currently approved compounds
as well as bringing new products to market, the Company's product portfolio
includes both late and early stage clinical drug candidates with the potential
for reduced risks and improved patient outcomes. The Company's refiled New
Drug Application for its lead product candidate immediate release Moxduo^® for
the treatment of acute pain, is presently under review at the US Food and Drug
Administration. QRxPharma has entered into strategic agreements with Actavis
Inc., Paladin Labs Inc., Aspen Group and Teva 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.

Forward Looking Statements
This 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 commercialisation of the Company's proposed
products.

SOURCE QRxPharma Limited

Website: http://www.qrxpharma.com
Contact: Lisa Fels, Brightline Strategies, Tel: +1 703 739 2424 x110, Email:
lfels@brightlinestrategies.com; Kyahn Williamson, Buchan Consulting, Tel: +61
401 018 828, Email: kwilliamson@buchanwe.com.au
 
Press spacebar to pause and continue. Press esc to stop.