QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain Therapy

* Reuters is not responsible for the content in this press release.

Mon Apr 20, 2009 9:45am EDT

QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain
Therapy

Primary Endpoints Met; Data Demonstrate MoxDuo(TM) IR Provides Better
Tolerability Than Morphine and Oxycodone Alone

SYDNEY, Australia and BEDMINSTER, N.J., April 20 /PRNewswire-FirstCall/ --
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the successful
completion of a Phase 3 program pilot study comparing the efficacy and safety
profile of MoxDuo(TM) IR against component doses of morphine and oxycodone. 
Results demonstrated that MoxDuo(TM) IR reduces pain significantly more than
its component doses; further, when compared to equianalgesic doses of morphine
and oxycodone, MoxDuo(TM) IR produced fewer and less intense side effects. 
These results confirm 12mg/8mg morphine plus oxycodone combination as the
preferred dose for optimal efficacy and tolerability as well as provide sample
size guidance for the upcoming Phase 3 Combination Rule study required for NDA
submission in 2010.  

"Having achieved statistical significance in measures of decreased pain
intensity with MoxDuo(TM) IR compared to its component doses, this pilot study
exceeded expectations.  Completed ahead of schedule and on budget, trial data
clearly demonstrated the clinical and commercial value of our patented
Dual-Opioid(TM), with the potential to give patients greater tolerability than
morphine or oxycodone alone," said Dr. John Holaday, Managing Director and
Chief Executive Officer, QRxPharma.  "From these data, we are confident that
our upcoming Phase 3 Combination Rule study will prove successful."

In this randomized, double blind study of 197 patients at 6 US clinical
research sites, MoxDuo(TM) IR was compared to morphine and oxycodone in
managing acute pain during the first 24 hours following a scheduled surgical
procedure (bunionectomy).  When postoperative pain reached a measure of at
least "4" (moderate pain, with 10 being the most severe) on the Numerical Pain
Rating Scale, patients received either MoxDuo(TM) IR, morphine or oxycodone
every 6 hours for 48 hours. The study's primary clinical endpoint was changes
in the pain intensity scores from baseline for MoxDuo(TM) IR versus component
doses of morphine and oxycodone alone. Secondary endpoints included: (1) pain
relief and global assessment of effect; and (2) safety as measured by the
incidence and intensity of opioid-related adverse events. 

In terms of reduced pain intensity scores and other related measures, the
analgesic effects of 12mg/8mg MoxDuo(TM) IR were 80-100% greater than the
components, morphine or oxycodone.  The 6mg/4mg MoxDuo(TM) IR dose also showed
similar improvements when compared to its individual components. 

Significantly, the frequency of moderate to severe adverse events (including
nausea, vomiting, constipation, dizziness, etc.) was 25% to 75% lower among
patients on MoxDuo(TM) IR compared to those receiving equi-analgesic doses of
morphine or oxycodone alone.  Furthermore, patients receiving morphine or
oxycodone alone were two to four times more likely to prematurely discontinue
dosing than those on MoxDuo(TM) IR.

"These data indicate that MoxDuo(TM) IR has the potential to provide superior
pain relief with a lower frequency and severity of side effects when compared
to either morphine or oxycodone," said Holaday.  "The improved tolerability
profile should enable pain practitioners to prescribe higher doses of
MoxDuo(TM) IR to achieve better pain relief with fewer side effects than
morphine or oxycodone alone." 

Additional studies evaluating MoxDuo(TM) IR versus Percocet(R) in patients
with joint replacement surgery are underway, with results expected in Q3 of
2009.

Forward Looking Statements   
This press release contains forward-looking statements that involve risks and
uncertainties.  The forward-looking statements contained herein represent the
judgment of QRxPharma as of the date of this release.  These forward-looking
statements are not guarantees for future performance.  Actual results could
differ materially from those currently anticipated to due to a number of
factors including 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 with a core focus on the development and
commercialization of new treatments for pain management and central nervous
system (CNS) disorders.  Based on a development strategy which focuses on
enhancing and expanding the clinical utility of currently marketed compounds,
the Company's product portfolio includes both late and early stage clinical
drug candidates with the potential for reduced risk, abbreviated development
paths, and improved patient outcomes.  The Company intends to directly
commercialize its products in the US and seek strategic partnerships abroad. 
QRxPharma's lead compound, MoxDuo(TM) IR, successfully completed a Phase 3
study and met 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

John Holaday, Managing Director and Chief Executive Officer, +1-301-908-3086,
john.holaday@qrxpharma.com, or Chris J Campbell, Chief Financial Officer and
Company Secretary, +61 2 9492 8021, chris.campbell@qrxpharma.com, both of
QRxPharma Limited; or Alicia Moran, PR Contact, +1-703-739-2424, ext. 110,
alicia@brightlinemedia.com, for QRxPharma Limited
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.