Seven-day transdermal buprenorphine gains FDA marketing approval for the treatment of chronic pain

Key Points

In patients with low back pain of at least moderate severity and lasting for at least 6 weeks, a new 7-day buprenorphine transdermal system was found to provide better pain control, improve sleep quality, and health-related quality of life as compared with placebo.

The results of this new randomized, double-blinded, crossover study were published in the May/June 2010 Pain Research and Management.

In this study, researchers randomly assigned 79 patients to receive either 5 µg/hour transdermal buprenorphine patches or placebo, with as-needed dose titration to a 10 µg/h or 20 µg/h patch done weekly. Acetaminophen 300 mg with codeine 30 mg (Tylenol #3), 1 to 2 tablets every 4 to 6 hours as needed was allowed for rescue analgesia.

In total, 53 patients (53% men; mean age 54.5±12.7 years) completed 2 weeks or more in each phase and were thus deemed evaluable. Most patients were titrated to the highest dose of transdermal buprenorphine patches (59% received 20 µg/h patch; 31% received 10 µg/h patch; 10% remained on the 5 µg/h patch). Transdermal buprenorphine patches resulted in lower mean daily pain scores than in the placebo group.

The researchers emphasized that the transdermal buprenorphine patch group, "…produced a 39.5% change from baseline for VAS scores and a 32.0% change from baseline for ordinal scores, indicating the response to active buprenorphine transdermal system was both statistically and clinically meaningful."

Not unexpectedly, patients receiving the transdermal buprenorphine patch experienced more opioid-related side effects than patients treated with placebo; however, there were no serious adverse events in either group. Despite these opioid-related side-effects, 82% of patients in the study opted to continue transdermal buprenorphine as part of a long-term open-label evaluation. Those who continued to receive long-term active treatment realized sustained improvements in pain intensity, functionality, and quality of life for up to 6 months.

As a result, transdermal buprenorphine (Butrans) was recently granted marketing approval by FDA on July 2, 2010. This new formulation is available as 5 µg/h, 10 µg/h, and 20 µg/h patches and is indicated 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.

SOURCES

Gordon A, Rashiq S, Moulin D, et al. Buprenorphine transdermal sysetem for opiod therapy in patients with chronic low back pain. Pain Res Manag. 2010;15(3):169-178.

Butrans Transdermal [package insert]. Stamford, CT: Purdue Pharma L.P.; 2010.