PALM SPRINGS, Calif — Bema buprenorphine (Endo Pharmaceuticals) consistently decreased pain scores when compared with placebo, according to two studies presented at the American Pain Society’s 34th Annual Scientific Meeting.
The drug, which is designed for use in patients with pain severe enough to require daily, long-term opioid treatment and for which alternative treatment options are inadequate, is currently under FDA review.
The phase 3 studies were both double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.
A total of 971 randomized patients completed both trials, including pain sufferers who either had received opioid therapy or were opioid-naive at the start of the study.
The studies included an open-label period in which patients were titrated to a tolerated, effective dose and then randomized to either continue on Bema buprenorphine or receive a placebo buccal film.
The primary endpoint of both studies was change in the average daily pain score from baseline to week 12 of double-blind treatment following the open-label titration period.
Overall, average pain scores increased more in the placebo arm versus Bema buprenorphine at week 12 from baseline, and the difference between the two groups was statistically significant:
A statistically significant percentage of patients on Bema buprenorphine experienced pain reductions of greater than 30 percent compared to placebo, according to a company press release.
1. Gimbel JS, et al. Abstracts 437 and 439. Presented at: APS 2015. March 13-16, 2015. Palm Springs, California.