QRxPharma announced that it has dosed the first patients with Q8003IR, an immediate release dual-opioid therapy in the first of several clinical trials.
The clinical trial is a double-blind, placebo-controlled study comparing the efficiency and safety of four dosage strengths of Q8003IR at eight US clinical research sites. The trial expects to enroll 250 patients who are experiencing moderate to severe post-operative pain following a bunionectomy.
"Initiation of this Phase III clinical trial program not only demonstrates the Company's ability to deliver on its development milestones for Q8003IR in terms of budget and time-line projections, but also represents a significant step forward towards our goal of commercializing our first dual-opioid pain therapy in 2010," said Dr. John Holaday,Managing Director and Chief Executive Officer, QRxPharma.
The primary endpoint of this acute, post-surgery pain study will focus on pain relief and pain intensity vs. placebo in the first 48 hours following surgery. A safety extension clinical trial will follow patient enrollment to compile longer-term patient safety data is support of an anticipated New Drug Application.
Q8003IR is an immediate release dual-opioid that combines sub-analgesic doses of oxycodone and morphine. Previous trials have shown that this combination achieves equal or better pain relief, at lower doses, and reduces side effects.
[Source: PRNewsWire]
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