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.