Transdermal buprenorphine effective for moderate-to-severe chronic low back pain

Transdermal buprenorphine (Butrans Transdermal System, Purdue Pharma) was superior to placebo in treating opioid-naïve patients with moderate-to-severe chronic low back pain, according to study results presented at the annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.

Transdermal buprenorphine (Butrans Transdermal System, Purdue Pharma) was superior to placebo in treating opioid-naïve patients with moderate-to-severe  chronic low back pain, according to study results presented at the annual meeting of the American Academy of Pain Medicine, in National Harbor, Md.

For this randomized, double-blind, placebo-controlled, parallel-group study, researchers included patients aged ≥18 years with moderate-to-severe low back pain for a minimum of 3 months prior to study entry. Using an enrichment design, researchers treated patients after the screening period with open-label buprenorphine during the run-in period (n=1,024), and then randomly assigned them to treatment with buprenorphine (10 µg or 20 µg; n=257) or matching placebo (n=284).

Week 12 average pain scores (APS) were statistically significantly better in the buprenorphine group compared with placebo (APS=-0.58; P=.0104). Greater proportions of patients with ≥30% and ≥50% pain score improvements were seen in the buprenorphine group.

A secondary end point in the study was the comparison of Medical Outcomes Study (MOS)-sleep disturbance subscale scores, which showed a statistically significant difference in favor of the buprenorphine group (P=.0062). The most common adverse events were nausea, application site rash, and headache.