Endo Pharmaceuticals announced positive top-line results from its Phase 3 efficacy study of BEMA Buprenorphine in opioid naïve subjects for the treatment of moderate to severe chronic pain. BEMA Buprenorphine is being tested as an around-the-clock opioid therapy for opioid naïve and opioid experienced patients.
In the enriched-enrollment, double-blind, randomized withdrawal study, 462 opioid naïve patients who titrated to a well-tolerated, effective dose were randomized to continue on that dose of BEMA Buprenorphine or receive placebo with treatment for 12 weeks. The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline to week twelve of the double-blind treatment period. The primary efficacy endpoint was met, as BEMA Buprenorphine resulted in significantly (P<0.005) improved chronic pain relief compared to placebo.
A second Phase 3 clinical study of BEMA Buprenorphine is currently underway with an opioid experienced patient group.
For more information call (484) 216-7158 or visit Endo.com.