• Lynn R Webster, Peter G Butera, Lauren V Moran, Nancy Wu, Lindsay H Burns, and Nadav Friedmann.
• Lifetree Clinical Research, Salt Lake City, Utah, USA.
• J Pain. 2006 Dec 1;7(12):937-46.

UnlabelledPhysical dependence or withdrawal is an expected effect of prolonged opioid therapy. Oxytrex (oxycodone + ultralow-dose naltrexone) is an investigational drug shown here to minimize physical dependence while providing strong analgesia with twice-daily dosing. In this 719-patient, double-blind, placebo- and active-controlled Phase III clinical trial in chronic low back pain, patients were randomized to receive placebo, oxycodone qid, or oxytrex qid or bid. Each oxytrex tablet contains 1 microg naltrexone; oxytrex bid and qid treatments provide 2 and 4 microg naltrexone/day, respectively. Following a washout, patients with pain >or=5 on a 0-10 scale were dose-escalated weekly from 10 up to 80 mg/day until reaching adequate pain relief (PerspectivePrevious clinical data have shown ultralow-dose naltrexone enhances and prolongs oxycodone analgesia, and preclinical data also show a suppression of opioid tolerance and dependence. A cellular mechanism of action has been demonstrated to be the prevention of aberrant G protein signaling by mu opioid receptors caused by chronic opioid administration.

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