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Dual Opioid Treatment Effective, Well Tolerated for Postoperative Pain: Presented at AAPM By Emma Hitt, PhD HONOLULU -- February 2, 2009 -- A fixed ratio of immediate-release (IR) morphine plus oxycodone (Q8003) appears to relieve acute postoperative pain and is well tolerated with minimal somnolence and respiratory depression, suggest results from a randomised, double-blind, placebo-controlled, ascending-cohort, dose-response study. Lynn R. Webster, MD, Lifetree Clinical Research & Pain Clinic, Salt Lake City, Utah, presented the findings here on January 30 at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting. According to the researchers, previous studies demonstrated that analgesia is enhanced when opioids with different receptor-binding properties are coadministered. Q8003 is currently in phase 2/3 trials for the treatment of postsurgical acute pain. Dr. Webster and colleagues examined the safety and efficacy of Q8003 in 256 patients undergoing unilateral bunionectomy. An ascending dose schedule was used, evaluating 4 doses of IR morphine/oxycodone: 3/2 mg; 6/4 mg; 12/8 mg; and 18/12 mg. Treatments were administered as needed over 48 hours, with at least 1 to 2 hours between doses. Each of the dose groups contained 48 to 50 patients. A group of 60 patients received placebo. Mean number of doses given ranged from 11.6 (of the 3/2 mg dose) to 5.2 (of the 18/12 mg dose). The highest mean dose for any group was 15/10 mg over 6 hours in the 18/12 mg dose group. Nausea (38%-65%) and dizziness (8%-25%) were the most common adverse effects. Most adverse events were transient and mild to moderate in severity. Minimal levels of respiratory depression were reported. One patient receiving Q8003 experienced sedation, while the incidence of somnolence ranged from 2% to 8%. The level of pain relief achieved with Q8003 therapy was greater than with placebo across the dose range as measured by the mean sum of pain intensity differences during the 48-hour treatment period (P = .0065). "Q8003 was associated with dose-related reductions in postoperative pain and even the lowest-dose group showed analgesic efficacy superior to placebo," the researchers concluded. "The low levels of respiratory depression and somnolence warrant further study." Funding for the study was provided by QRxPharma. [Presentation title: Dual Opioid Treatment of Acute Postoperative Pain: A Double-Blind, Placebo-Controlled Study. Abstract 232] E-mail this page to a friend or colleague! To print, use this version