SYDNEY, Australia and BEDMINSTER, N.J., Sept. 1
/PRNewswire-FirstCall/ — QRxPharma (ASX: QRX and OTCQX: QRXPY)
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
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