FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Jul 2 2010

Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) 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 Transdermal System is an analgesic product that 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.  

The active ingredient in Butrans Transdermal System is buprenorphine, a partial agonist at mu opioid receptors and an antagonist at kappa opioid receptors.  Butrans is a Schedule III product.  Butrans can be abused in a manner similar to other opioid agonists, legal or illicit.  Working with the FDA, Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes a Medication Guide, Elements to Assure Safe Use, such as healthcare providers training, and a timetable for submitting assessments of the REMS.  

"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. "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."  

Butrans is indicated 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.