August 6, 2010 – Stamford, CT based 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.
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 and has the potential to be abused in a manner similar to other opioid agonists, legal or illicit. In conjunction 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 provider training), and a timetable for submitting assessments of the REMS.
The efficacy of Butrans has been evaluated in four 12-week double-blind, controlled clinical trials in opioid-naïve and opioid-experienced patients with moderate to severe chronic low back pain or osteoarthritis using pain scores as the primary efficacy variable. Two studies in low back pain demonstrated efficacy while one study in low back pain failed to show efficacy and one study in osteoarthritis that included an active comparator, failed to show efficacy for Butrans and the active comparator.
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 (such as patients who need relief of post-operative pain), 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. Doses should not exceed one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. Butrans patches should not be cut or divided or used if damaged. 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. Purdue expects to launch Butrans in early 2011.
For more information, please go to: http://www.purduepharma.com/html/our_products/our_products.htm
