clinical-stage specialty pharmaceutical company focused on the development
and commercialisation of therapies for pain and central nervous system
(CNS) disorders, announced initial Phase 3 efficacy results for
Q8003IR, an immediate release dual-opioid product intended for the acute
management of moderate to severe pain.
"Initial Phase 3 efficacy data demonstrated statistically significant
analgesic activity at all doses tested and reinforces the potential
clinical benefit and commercial value of QRxPharma's lead dual-opioid
product," said Dr. John Holaday, Managing Director and Chief Executive
Officer, QRxPharma. "We are pleased with this study outcome and believe
that it demonstrates that the Company remains on target to complete
clinical testing for Q8003IR, submit a New Drug Application (NDA) in 2009
and achieve its goal of product launch in 2010."
The double-blind, placebo-controlled study was designed to compare the
efficacy and safety of four different dosage regimens of Q8003IR, a fixed
ratio morphine/oxycodone combination. 256 patients with moderate to severe
pain following surgery (bunionectomy) completed the trial, and it was
conducted at six US clinical research sites. The primary efficacy analysis
compared the change in pain intensity scores over the 48 hr dosing period
(SPID48) in patients receiving Q8003IR vs. placebo.
Among all patients receiving Q8003IR, approximately 50% reported good
to excellent global improvement (vs. 13% for placebo) and demonstrated a
strong dose-response effect (p<0.001) in reducing pain intensity scores
[i.e. the sum of pain intensity difference over 48 hours relative to the
first dose (SPID48)] and other measures of analgesic effect. Per treatment
group, median doses received every 4 hours ranged from 3mg/2 mg to 9mg/6 mg
of morphine/oxycodone.
The data further demonstrate that Q8003IR was generally well tolerated,
with a low rate of patient withdrawal (2% to 12% depending on dose vs. 2%
for placebo). In addition, there was minimal somnolence (2% to 8%) and
changes to respiratory parameters (respiration rate, oxygen saturation)
with no incidences of euphoria reported. Nausea and vomiting (usually mild)
were the most common adverse events. Further analysis of side effect
profiles is underway and these data will be available by late May 2008.
Q8003IR is a patent-protected combination of morphine and oxycodone
which has been clinically shown to provide synergistic effects on pain
relief with a significant reduction of total opioid dose and side effects.
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 (ASX: QRX) 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
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, Q8003IR, successfully completed a Phase 3 study and met primary
endpoints. The Company's preclinical and clinical pipeline includes other
technologies in the fields of pain management, neurodegenerative disease
and venomics. For more information: http://www.QRxPharma.com
QRxPharma
http://www.qrxpharma.com
View drug information on Oxycodone and Aspirin.
