This initial clinical trial is designed to compare the efficacy and safety of four different dosage strengths of Q8003IR versus placebo in a post-surgery, acute pain setting. The study is being conducted at eight US clinical research sites and is targeted to enroll 250 patients experiencing moderate to severe pain following a scheduled surgical procedure (bunionectomy).
John Holaday, managing director and CEO of QRxPharma, said: “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.”