Stamford, CT — Purdue Pharma L.P. announced 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.
Butrans is contraindicated in patients who have significant respiratory depression, severe bronchial asthma, who have or are suspected of having paralytic ileus or known hypersensitivity to any of its components or the active ingredient, buprenorphine, as well as those who require opioid analgesia for a short period of time, who require the management of post-operative pain, including use after out-patient or day surgeries, the management of mild pain, and the management of intermittent pain (e.g., use on an as needed basis).
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.
Warnings and precautions:
-- Use with extreme caution in patients at risk of respiratory depression.
-- Use with caution in patients who are receiving other central nervous system (CNS) depressants.
-- Additive CNS effects are expected when used with alcohol, benzodiazepines, other opioids, or illicit drugs.
-- Avoid in patients with Long QT Syndrome, a family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications.
-- Butrans may worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs.
-- Use with caution in patients at increased risk of hypotension and in patients in circulatory shock.
-- Ileus may occur; monitor for decreased bowel motility.
-- Use with caution in patients with biliary tract disease, including acute pancreatitis.
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