Send to printer »

GEN News Highlights : Jul 2, 2010

FDA Approves Purdue’s Opioid Patch for Chronic Pain

Transdermal system was shown to be effective in trials of patients with moderate to severe low-back pain.

FDA approved Purdue Pharma’s Butrans™ Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans is an analgesic patch that delivers continuous release of medication for seven days.

The active ingredient in Butrans is buprenorphine, a partial agonist at mu opioid receptors and an antagonist at kappa opioid receptors. Three strengths of Butrans are available: 5, 10, and 20 mcg/hour; each single patch is intended to be worn for one week.

Evidence of Butrans’ efficacy has been provided through the study of more than 1,200 patients in two pivotal analgesic trials. One trial enrolled patients who were opioid-naive while the other enrolled patients who were opioid-experienced. Each of these two trials enrolled patients suffering from moderate to severe chronic low-back pain, included a 12-week double-blind phase, and utilized pain scores as the primary efficacy variable. Butrans improved pain scores in both the opioid-naive and opioid-experienced patients.