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QRxPharma Releases Successful Phase 3 Study Results For 'Dual Opioid' Pain Therapy
QRxPharma Limited (ASX: QRX), a
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
QRxPharma versiuni de succes studiu de fazã 3 rezultate pentru "dual Consumul de opiacee" Terapia durerii - QRxPharma Releases Successful Phase 3 Study Results For 'Dual Opioid' Pain Therapy - articole medicale engleza - startsanatate