QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it has completed patient enrolment for a pivotal Phase 3 registration trial (Study 009) for MoxDuo IR.  The comparative study was designed to evaluate analgesic efficacy and safety of MoxDuo IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone, for managing moderate to severe pain in patients who have undergone total knee replacement surgery.

This double-blind, two-arm study comparing a flexible analgesic dose regimen of MoxDuo IR vs. a fixed low dose enrolled 141 patients (approximately 70 per treatment group) at 10 US clinical locations. Due to the number of hospital sites reporting and potential delays over the holiday season, the company expects to release top-line data in February 2011, prior to the filing of its New Drug Application (NDA) for MoxDuo IR with the US Food and Drug Administration.

“When this study reached 50% enrolment, we reported an interim data analysis that indicated a greater than a 90% probability of successfully detecting differences in analgesic effect.  Now that patient enrolment is complete, we are optimistic that pending analysis of the final data will confirm statistical significance,” said Dr. John Holaday, Managing Director and CEO, QRxPharma.  “In study after study, MoxDuo IR has consistently demonstrated as good or better pain relief with fewer incidences of moderate to severe side effects than current standards of care.  We expect that this study will not only achieve the primary analgesic endpoint, but also satisfy the remaining clinical study requirements for NDA filing.”

MoxDuo IR targets the acute pain market, a $2.5 billion segment of over $7 billion spent annually on prescription opioids in the US. In April 2010, the company released results from a “combination rule” pivotal study (008) comparing the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.  MoxDuo IR not only demonstrated a statistically superior analgesic effect compared to component doses of morphine (p=0.02) and oxycodone (p=0.02) but, also, a favourable side effect profile despite delivering twice the opioid dose of its individual components. This trial met both primary and secondary endpoints. With the successful completion of this knee replacement study (009), the company believes it has met the basic requirements for clinical data to enable NDA filing for MoxDuo IR as targeted for the first half CY2011.

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