Purdue Pharma Receives FDA Approval for Butrans™ Transdermal System For Severe Pain Management

Purdue is the same company that brought us Oxycontin and the patches are supposed to be a safer way to release the pain medication and again, don’t put more than one patch on of course. It does contain an opioid controlled substance so available only by prescription and is worn for 7 days.

The warning below says Butrans (buprenorphine) could be habit forming. BD

STAMFORD, Conn., July 1 /PRNewswire/ -- 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.

Three strengths of Butrans are available: 5, 10, and 20 mcg/hour; each single patch is intended to be worn for seven days. Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death.

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, POTENTIAL FOR ABUSE, AND LIMITATIONS OF USE

Proper Patient Selection
Butrans is a transdermal formulation of buprenorphine 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.

Potential for Abuse
Butrans contains buprenorphine which is a mu opioid partial agonist and a Schedule III controlled substance. Butrans can be abused in a manner similar to other opioid agonists, legal or illicit. Consider the abuse potential when prescribing or dispensing Butrans in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction.

Limitations of Use
Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation.

Avoid exposing the Butrans application site and surrounding area to direct external heat sources. Temperature-dependent increases in buprenorphine release from the system may result in overdose and death.