Newly FDA Approved 7-day Buprenorphine Patch

Butrans™ (buprenorphine) once-weekly transdermal patches, manufactured by Purdue Pharma LP, were approved July 1 by the FDA for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid analgesia for an extended period of time. Buprenorphine is a schedule III controlled substance, previously only available in oral and injectable formulations, which will be available in 5, 10 and 20µg/hour patches.  The narcotic analgesic patches are unique in that they provide continuous pain relief by slowly releasing the active ingredient over a course of seven days.  Possible side effects include itching or rash at application site, constipation, dizziness, drowsiness, nausea  and vomiting. Similar to other narcotics, buprenorphine patches are linked to a risk for misuse, abuse and diversion, mainly in patients with a history of substance abuse and/or mental illness. The use of Butrans is contraindicated in the management of acute or short-term pain, postoperative pain, mild pain and intermittent pain. 

Butrans  is not currently available, but is expected to be released in early 2011. Progressive MedicaI’s clinical team will provide an update when this new product is on pharmacy shelves. 

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2. Waknine, Y. FDA approves 7-day buprenorphine pain patch. Medsape. Published: 07/08/2010. Accessed: 07/15/2010. Available from: http://www.medscape.com/viewarticle/724626