The Pharmaceutical Journal
Vol 276 No 7400 p559
13 May 2006

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Oxycodone plus low-dose naltrexone effective for pain relief

A combination of oxycodone and low-dose naltrexone shows promise as an analgesic while minimising physical dependence, according to data from a phase III study presented at the American Pain Society meeting held in San Antonio, Texas, last week.

In the study, 719 patients with chronic moderate to severe low back pain were randomised to receive placebo, oxycodone or oxytrex (the combination product). During the 12-week study patients treated with oxytrex attained pain relief equivalent to that in patients treated with oxycodone alone despite a lower oxycodone dose (P=0.03). They also reported 44 per cent less moderate to severe constipation (P=0.01) and 33 per cent less drowsiness (P=0.03) Furthermore, following cessation of opioid treatment, patients taking the combination product were less likely to report physical dependence (P=0.01).

Pain Therapeutics Inc, the company developing the product, says the rationale behind its approach is that the addition of naltrexone (an opioid receptor antagonist that crosses the blood-brain barrier) slows the development of opioid tolerance, thereby minimising both the dose of active drug needed and the resulting side effects.