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, the first combination opioid product for the
improved control of moderate to severe pain, successfully completed a Phase 3
study and a pilot Combination Rule 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
CONTACT: 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 (x110),
alicia@brightlinemedia.com,
for QRxPharma Limited
(QRX)
(QRXPY)
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 www.QRxPharma.com.
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