QRxPharma Announces Interim Analysis of Final Pivotal Phase 3 Study for MoxDuo IR
On track to achieve primary pain relief endpoint in patients following total knee replacement
SYDNEY, Australia and BEDMINSTER, N.J., Sept. 1
/PRNewswire-FirstCall/ -- QRxPharma announced today a successful
interim analysis of its final MoxDuo IR pivotal Phase 3 study
required for New Drug Application (NDA) submission. The analysis
indicated the planned sample size of 140 patients has greater than
90% power to detect differences of analgesic effect, indicating
there is no need to enrol additional patients. QRxPharma
anticipates completing analysis of this study in Q4 CY2010 and
filing a New Drug Application (NDA) for MoxDuo IR in Q1
CY2011.
"It's certainly exciting - as we near completion of our MoxDuo
IR clinical program - that interim analysis of the final pivotal
study indicates we're on track to obtain significant results," said
Dr. John Holaday, Managing Director and CEO. "In study after study
this product has performed consistently, successfully achieving
every primary end-point. Our emphasis has been to de-risk the
MoxDuo IR clinical development program, and these data give us
confidence that completion of this study will achieve primary pain
relief endpoints and satisfy requirements for NDA filing."
QRxPharma is currently completing its product registration
clinical program for MoxDuo IR (a 3:2 ratio of morphine to
oxycodone) in the management of moderate to severe acute pain. This
comparative study conducted at 10 centres in the US, now well over
halfway complete, is evaluating analgesic efficacy and tolerability
of a flexible dose regimen (12 mg/8 mg) versus a fixed low dose (3
mg/2 mg) of MoxDuo IR in 140 patients with moderate to severe pain
following total knee replacement surgery.
The study design included a blinded interim analysis (70
completed patients) to be conducted by an independent statistician
for the purpose of sample size confirmation. This interim analysis
indicated that the projected sample size of 140 patients is likely
to provide sufficient power to distinguish the analgesic effects of
flexible dose versus fixed low dose of MoxDuo IR over a 48 hour
study period. Since the blinded interim analysis was based on how
much variability was observed when both dosage groups were combined
and did not evaluate the magnitude of the difference between the
two treatment groups per se, one must be cautious in drawing
conclusions that the expected endpoints will be met. This type of
interim analysis conducted for the purpose of sample size
re-estimation, which was accepted by the FDA, does not result in a
statistical penalty in the p-values of the final analysis to be
conducted upon study completion.
For more information please contact: Dr John W Holaday Managing Director and Chief Executive Officer Tel: +1 301 908 3086 Email: john.holaday@qrxpharma.com Chris J Campbell Chief Financial Officer and Company Secretary Tel: +61 2 9492 8021 Email: chris.campbell@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.
About QRxPharma
QRxPharma 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 co-promote its products in the US and seeks
strategic partnerships for worldwide markets. QRxPharma's lead
product candidate, MoxDuo IR, is in Phase 3 clinical development
and has successfully completed multiple comparative studies
evaluating its efficacy and safety against equi-analgesic doses of
morphine, oxycodone and Percocet® for the treatment of acute
pain. QRxPharma expects to complete its Phase 3 program in Q4
CY2010 and file its New Drug Application (NDA) with the US Food and
Drug Administration (FDA) for MoxDuo IR in Q1 CY2011. The Company's
preclinical and clinical pipeline includes other technologies in
the fields of pain management, neurodegenerative disease and
venomics. For more information, visit www.qrxpharma.com.
Source: QRXPharma
CONTACT: Alicia Moran, +1-410-991-7027
Web Site: http://www.qrxpharma.com/
Posted: September 2010
