Butrans Tansdermal System CIII has been approved by FDA. Butrans is now available by prescription and is indicated for 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 a skin patch containing the opioid buprenorphine that “delivers a continuous release of medication for seven days”. The active ingredient in Butrans is buprenorphine which like any other opioid agonists, can be abused. As such, Purdue Pharma, the maker of Butrans worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) for Butrans that includes Medication Guide, Elements to Assure Safe Use, such as healthcare providers training and a timetable for submitting assessments of the REMS.
The patch comes in 5, 10 and 20 mcg/hour doses and is designed to be worn for seven days. Purdue Pharma’s President and CEO said that they are “pleased with the FDA approval of Butrans and believe it will be a valuable pain management option for healthcare professionals and patients.“
Butrans Transdermal System is the first opioid analgesic that delivers continuous release of buprenorphine for seven days.