MEDIA RELEASE PR35827
MoxDuo(TM) IR Demonstrates Fewer Side Effects than Percocet(R)
SYDNEY and BEDMINSTER, N.J., Aug. 26 /PRNewswire-AsiaNet/ --
Pain relieving effects of MoxDuo(TM) IR are dose-related with a better safety profile than Percocet(R) in patients
with post-operative pain following total knee replacement
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today successful completion of its pilot study
to evaluate the analgesic efficacy and safety profile of MoxDuo(TM) IR (immediate release) capsules in patients
with moderate to severe pain following total knee replacement surgery. When compared at equianalgesic doses
with Percocet(R), the second most widely prescribed opioid in the US, MoxDuo(TM) IR demonstrated greater
overall tolerability with substantially fewer incidences of moderate to severe nausea, vomiting, constipation, and
hypotension than Percocet(R). Scheduled for launch in 2011, MoxDuo(TM) IR targets the acute pain market; a $2.5
billion segment of the $7 billion spent annually on prescription opioids in the US.
"This study serves to reinforce earlier clinical findings that showed improved tolerability and again demonstrates
the value of our Dual-Opioid(TM) platform as MoxDuo(TM) IR opens the therapeutic window for treating patients
suffering from acute post-surgical pain," said Dr. John Holaday, Managing Director and Chief Executive Officer,
QRxPharma. "We believe the MoxDuo(TM) product portfolio - including immediate release, controlled release and
intravenous formulations - will significantly improve patient care, providing equal or better analgesia with fewer
and/or less intense side effects than current standards of care."
MoxDuo(TM) IR is the first patented analgesic product in the world that consists of two opioid drugs (a fixed ratio
of morphine and oxycodone). While many analgesic combination drugs exist that contain opioids with mild pain
drugs such as aspirin, ibuprofen or acetaminophen, combination products such as Percocet(R) - which contains an
opioid (oxycodone) combined with acetaminophen (like Tylenol(R)) - have been the subject of recent FDA scrutiny
due to their potential for causing significant adverse effects on liver and gastrointestinal function.
To date, more than 400 patients in six clinical trials have received MoxDuo(TM) IR for different forms of post-
surgical pain (bunionectomy and total knee replacement). Study results with MoxDuo(TM) IR consistently
demonstrate fewer side effects than observed with morphine alone, oxycodone alone and now with Percocet(R).
In this open label trial, each group of patients who experienced moderate to severe post-operative pain following
total knee replacement surgery were treated every four to six hours over a 48-hour period. The study enrolled a
total of 44 patients at five US clinical research sites.
All primary study objectives were met comparing: (1) the analgesic efficacy and safety profile of MoxDuo(TM) IR
against control groups of patients receiving Percocet(R), a frequently used opioid for the treatment of pain; and (2)
a flexible dosing regimen of MoxDuo(TM) IR against a fixed low dose (3/2mg). Patients receiving the flexible dosing
regimen of MoxDuo(TM) IR achieved significantly greater pain relief than those receiving the low dose formulation
(p<0.05).
Data collected from this study provide additional guidance for optimising the design and implementation of
pending pivotal Phase 3 studies as the Company prepares for New Drug Application (NDA) filings with the US
Food and Drug Administration (FDA) in 2010.
MoxDuo(TM) IR, the Company's lead product candidate, is part of a larger Dual-Opioid(TM) portfolio including
intravenous (MoxDuo(TM) IV) and controlled release (MoxDuo(TM) CR) formulations. These formulations are
designed to incorporate tamper resistance and reduced abuse liability as appropriate.
Dr. Bruce Nicholson, a leading pain physician in the US, commented on these results: "The concept of
combining morphine and oxycodone makes sense based on the clinical data generated to date, and has benefited
my patients in managing their acute and chronic pain needs. Results of this study reinforce that the clinical
advantages of MoxDuo(TM) IR have the potential to change the traditional methods of treating moderate to severe
pain by providing better pain relief without many of the debilitating side effects seen with traditional opioid drugs."
Based on the Company's July 2008 FDA meeting, final Phase 3 studies for MoxDuo(TM) IR will include: (1) a
"double-blind combination rule" trial in patients experiencing post-surgical (bunionectomy) pain that compares
MoxDuo(TM) IR against morphine alone and oxycodone alone and (2) a double-blind controlled study to evaluate
the effectiveness of MoxDuo(TM) IR in patients following total knee replacement. No additional pharmacology,
toxicology or long-term clinical safety studies will be required for regulatory submission and market approval.
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 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
commercialisation of the Company's proposed products.
About QRxPharma
QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on
the development and commercialisation 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 commercialise 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, please visit
SOURCE: QRxPharma
CONTACT: Alicia Moran,
PR contact,
+1-703-739-2424 x110,
Alicia@brightlinemedia.com,
for QRxPharma;
Chris Campbell, CFO,
QRxPharma,
6129492 8021,
chris.campbell@qrxpharma.com
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