Buprenorphine buccal film effective for moderate, severe chronic low back pain

Buprenorphine buccal film treatment led to greater reductions in pain than placebo among patients with moderate or severe chronic low back pain with and without previous opioid exposure, according to research presented at this year’s virtual PAINWeek meeting.

“Buprenorphine is a unique opioid that has demonstrated analgesic efficacy and favorable safety properties that may result in an improved risk-benefit profile relative to other opioids,” Mancia Ko, PharmD, MBA, senior director of medical affairs at BioDelivery Sciences International, said during the presentation. “Buprenorphine buccal film [(BELBUCA; BioDelivery Sciences International, Inc.)] is FDA-approved for the management of pain severe enough to require daily, around-the-clock, long-term, opioid treatment, and for which alternative treatment options are inadequate.”

Researchers conducted a post-hoc analysis of data from two phase 3 clinical trials that established the efficacy of buprenorphine buccal film for chronic low back pain in patients with and without exposure to opioids to evaluate the efficacy of the treatment based on baseline pain severity.

Both studies included adults who had chronic low back pain for at least 6 months. In their last week of screening, participants had an average pain intensity score of 5 or higher on an numerical rating scale that ranged from a score of 0, or no pain, to a score of 10, or the worst pain imaginable. Opioid-experienced patients with well-controlled pain who had scores of less than 5 on the scale were included if their pain scores were 5 or higher for 3 consecutive days or longer when they were tapering off their last opioid.

During the open-label phase of the study, participants underwent titration to their optimal dose of buprenorphine buccal film, then were randomly assigned to continue the treatment at their optimal dose or to receive a placebo buccal film every 12 hours for 12 weeks.

A total of 971 participants were included in the study, with 483 assigned to buprenorphine buccal film and 488 assigned to placebo buccal film. Among participants, the mean pain scores before titration were similar in both groups at the start of the double-blind period.

Researchers determined that improvements in pain scores were overall significantly greater in the buprenorphine buccal film groups than in the placebo group at every assessment at 10-day intervals.

They found significantly greater decreases in pain score among participants with moderate to severe pain in the buprenorphine buccal film group compared with the placebo group. However, this was not seen in participants who had mild pain.

According to researchers, the largest difference in pain scores between the buprenorphine buccal film and placebo groups was at day 50 in those with moderate pain (mean difference = 1.0; 95% CI, 1.5 to 0.6) and at day 60 and day 70 in those with severe pain (mean difference = 0.8; 95% CI, 1.1 to 0.5).

They also determined that the mean differences in pain scores between the buprenorphine buccal film group and the placebo group were the same or greater for patients with moderate pain than for patients with severe pain at each 10-day interval.

Ko said the findings provide more evidence that the treatment is effective for chronic low back pain in patients with and without previous exposure to opioids.

“Given the favorable risk-benefit profile of buprenorphine, buprenorphine buccal film should be considered a treatment option for patients who require long-term opioid treatment, even when their pain levels are considered severe,” Ko said.