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www.fdanews.com/articles/82067-pain-therapeutics-gives-update-on-oxytrex-trial

PAIN THERAPEUTICS GIVES UPDATE ON OXYTREX TRIAL

October 31, 2005

Pain Therapeutics has provided an update on its progress with its Phase III clinical program for Oxytrex. Oxytrex (oral oxycodone plus ultra-low-dose naltrexone) is an investigational drug in late-stage clinical development for the treatment of moderate-to-severe chronic pain.

The Phase III study enrolled more than 700 patients with severe low-back pain. This randomized, double-blind, multicenter study was designed to compare the safety and efficacy of a variable dose of Oxytrex versus oxycodone or placebo.

Among other benefits, Oxytrex patients reported a significant reduction in physical dependence and withdrawal effects in the first 24 hours following cessation of prolonged, high-dose therapy compared to patients on oxycodone.