FDAnews
www.fdanews.com/articles/70287-pain-therapeutics-announces-positive-oxytrex-phase-iii-results

Pain Therapeutics Announces Positive Oxytrex Phase III Results

March 25, 2005

Pain Therapeutics has reported clinical results from the first of two Phase III trials with Oxytrex, a novel oral opioid painkiller.

In this Phase III study of 719 patients with severe, chronic low-back pain, Oxytrex patients reported more than 50 percent fewer symptoms of physical dependence and withdrawal effects after cessation of prolonged, high-dose opioid therapy compared to patients on oxycodone.

Oxytrex patients reported equal pain relief to patients on oxycodone and roughly 20 percent fewer overall opioid-related side effects during treatment, including less somnolence, less pruritus and 44 percent less moderate-to-severe constipation.