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 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.
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