BEMA buprenorphine (Belbuca) decreases pain scores in two Phase III studies in patients with chronic lower back pain.-Endo + Biodelivery Sciences

Endo Pharmaceuticals Inc. and BioDelivery Sciences International, Inc. presented pivotal data from two Phase III studies for investigational study drug buprenorphine HCL buccal film utilizing BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology ( Belbuca). The findings, presented at the American Pain Society's 34th Annual Scientific Meeting in Palm Springs, CA , showed BEMA buprenorphine consistently decreased pain scores compared to placebo. The drug is currently under review by the FDA with a PDUFA action date in October 2015 , for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.The Phase III 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 (study EN3409-307; abstract 437) or were opioid-naive at the start of the study (study EN3409-308; abstract 439). The studies included an open-label period in which patients were titrated to a tolerated, effective dose of BEMA buprenorphine 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. BEMA buprenorphine is delivered using BDSI's patented BEMA drug delivery technology, which efficiently and conveniently delivers buprenorphine across the buccal mucosa (inside lining of the cheek). 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: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: (EN3409-307/opioid experienced population) mean score change: 1.92, placebo versus 0.88, BEMA buprenorphine; p<0.00001. (EN3409-308/opioid naive population) mean score change:1.59, placebo versus 0.94, BEMA buprenorphine; p=0.0012. A statistically significant percentage of patients on BEMA buprenorphine experienced pain reductions of greater than 30 percent compared to placebo (EN3409-307: 64.2 percent versus 30.6 percent; p<0.0001; EN3409-308: 62.7 percent versus 46.9 percent; p=0.0012).A statistically significant percentage of patients on BEMA buprenorphine experienced pain reductions of greater than 30 percent compared to placebo (EN3409-307: 64.2 percent versus 30.6 percent; p<0.0001; EN3409-308: 62.7 percent versus 46.9 percent; p=0.0012).