Butransâ„¢ Approved by FDA for Pain Management

Butrans™ (buprenorphine) Transdermal System CIII was approved by the FDA for treating moderate to severe chronic pain in patients that require a continuous opioid analgesic for an extended period of time.

The product is produced by Purdue Pharma L.P. and delivers continuous release of medication for seven days.

"Healthcare professionals now have an important new option for appropriate adult patients suffering from moderate to severe chronic pain when an opioid may be needed to manage their pain," said Lynn R. Webster, MD, FACPM, FASAM, medical director of the Lifetree Clinical Research and Pain Clinic in Salt Lake City, Utah, in a press release.

The active ingredient is buprenorphine. The FDA has worked with Purdue to develop a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes a medication guide, elements to assure safe use, and a timetable to submit assessments of REMS. Butrans is a schedule III product and like similar opioid agonists can be abused.

"We are very pleased with the FDA approval of Butrans and believe that it will be a valuable pain management option for healthcare professionals and patients," said John H. Stewart, president and CEO of Purdue Pharma L.P., in a press release. "We are committed to improving the lives of patients in meaningful ways, including developing safe and effective therapies as well as offering educational tools and information that support their safe and proper use."