Buprenorphine Safe, Effective in Patients with Chronic Low Back Pain

Study results show that buprenorphine is an effective option for adult patients suffering from moderate to severe chronic pain.

Yesterday at the 2011 annual meeting of the American Academy of Pain Medicine (AAPM), researchers presented study results that demonstrated the analgesic efficacy and safety of Butrans for the relief of moderate to severe chronic low back pain in opioid-naive patients.

A news release from the AAPM summarized the results of a randomized, double-blind, 12-week study in which more than 1,000 patients “were treated with Butrans during the open-label run-in period and were randomized to Butrans 10 and Butrans 20, or matching placebos.” The primary efficacy endpoint was "average pain over the last 24 hours" at Week 12 of the study.

Deborah Steiner, MD, MS, medical director at Purdue Pharma, said “In the open-label run-in period, if Butrans 10 was tolerated but adequate analgesia was not reached, the dose was increased to Butrans 20 for an additional 10 to 12 days.” She said that "Patients who achieved adequate analgesia and tolerated Butrans were then randomized to remain on the titrated dose of Butrans (10 or 20) or a matching placebo. To demonstrate adequate analgesia in the open-label run-in period, patients had to have pain scores of less than or equal to 4 on an 11-point scale for 3 consecutive days and at least a 2-point reduction from their screening pain scores."

According to the news release, researchers reported “a statistically significant treatment difference of -0.58 in favor of Butrans over placebo (P=.0104).” They also reported that “the proportions of patients with at least 30% and at least 50% pain score improvements were larger for Butrans-treated patients.”

"We were able to demonstrate that Butrans was superior to placebo in treating opioid-naive patients with moderate to severe chronic low back pain and that the safety profile of Butrans is consistent with that associated with opioid analgesics and transdermal patches,” said Steiner.

Additional information about Butrans (buprenorphine) transdermal system:

Full prescribing information for Butrans

Butrans medication guide

Information about the Risk Evaluation and Mitigation Strategy (REMS) for Butrans, which includes “a medication guide; elements to assure safe use, such as healthcare providers training; and a timetable for submitting assessments of the REMS.”