New Pain Patch Receives FDA Approval: Butrans
The FDA has approved Butransâ„¢ (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. The Butrans Transdermal System is an analgesic product that delivers a continuous release of medication for seven days.
Butrans is an opioid and is classified as a Schedule III controlled substance. That means there is some potential for abuse, but less than for Schedule II drugs like oxycodone and morphine. It can also be prescribed with up to five refills.
Three strengths of Butrans are available: 5, 10, and 20 mcg/hour; each single patch is intended to be worn for seven days. It is recommended for patients who need 80 mg/day or less of morphine-equivalent opioid medication. Note: The use of other extended-release opioids must be reduced before starting buprenorphine treatment.
No more than one 20 mcg/hour patch should ever be used at a time due to the risk of QTc interval prolongation, which can result in sudden cardiac death. The site of the patch application and the surrounding area should not be exposed to direct external heat sources, like a heating pad, because that could cause too much medication to be released at once, resulting in possible overdose and/or death.
The active ingredient in the Butrans Transdermal System is buprenorphine, a partial agonist at mu opioid receptors and an antagonist at kappa opioid receptors. It has been suggested that buprenorphine has a wider safety profile than full mu-opioid agonists and milder withdrawal signs and symptoms when it is discontinued.
Working with the FDA, Purdue Pharma L.P., manufacturers of Butrans, have developed a Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide, Elements to Assure Safe Use, such as health care providers training, and a timetable for submitting assessments of the REMS.
The most common side effects reported by patients treated with Butrans in clinical trials were nausea, headache, application site pruritis (itching), dizziness, constipation, somnolence (drowsiness), vomiting, application site erythema (redness), dry mouth, and application site rash.
Source: Purdue Pharma L.P. Receives FDA Approval for Butransâ„¢ (buprenorphine) Transdermal System CIII. PR Newswire Press Release. July 1, 2010.