The Hospice Clinician Blog

The FDA has recently approved Butrans, a new transdermal opioid patch. The opioid in Butrans, buprenorphine, has been available in the U.S . for several years in the form of Suboxone and Subutex sublingual tablets. The buprenorphine patch has been used for the management of chronic pain in Europe for years under the brand name of Norspan, but it is new to the U.S. market.

The transdermal patch is available in three strengths, 5mcg/hr, 10mcghr, and 20mcg/hr and provides continuous release of the medication for seven days. It is classified as a DEA schedule III controlled substance, similar to moderate-strength opioids such as Vicodin or Norco. Butrans is indicated for chronic severe non-malignant pain when lower doses of strong opioids are indicated. The highest strength Butrans patch (20mcg/hr) is approximately equivalent to 50mg of oral morphine per day. Doses greater than 20mcg/hr are not recommended due to the potential for adverse cardiac effects (QTc prolongation).

Buprenorphine is a partial mu opioid agonist. This means that, even though buprenorphine is an opioid that can produce typical opioid agonist effects (analgesia) and side effects (euphoria and respiratory depression) in hospice patients, its maximal effects are less than those of full agonists such as morphine and methadone. The agonist effects of buprenorphine increase linearly with increasing doses of the drug until at moderate doses they reach a plateau and no longer continue to increase with further increases in dose—the “ceiling effect.” For this reason, buprenorphine is believed to have a lower risk of abuse, addiction, and side effects compared to full opioid agonists. In high doses, buprenorphine may actually trigger some opioid withdrawal symptoms in persons who have been receiving other opioids and have developed some physical dependence, however, this effect may not be clinically significant at the lower doses employed with the transdermal patch.

The Butrans patch is not indicated for management of short-term post-operative pain, but may be beneficial for management of chronic severe pain in hospice patients who are vomiting or have swallowing difficulties. The eventual role of the Butrans patch in chronic pain management is still being established. Cost for the new drug was not available at the time of this post, however, as with all new branded medications, we can expect a hefty price-tag.

http://www.purduepharma.com/PI/prescription/ButransPI.pdf

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