Endo Pharmaceuticals Inc., a subsidiary of Endo International plc and BioDelivery Sciences International, Inc. announced today positive top-line results from its pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients. BEMA buprenorphine is being developed 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 in both patients who are opioid naive and opioid experienced.
The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.0001) improved chronic pain relief compared to placebo.
Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo. The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (7.5% vs. 7.4 and vomiting (5.5% vs. 2.3%).
"We are highly encouraged by today's announced study results, which we believe are meaningful for appropriate patients requiring an opioid," said Dr. Susan Hall, executive vice president, chief scientific officer and global head of research and development and quality. "And we look forward to now focusing on our upcoming pre-NDA meeting this month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as soon as possible." "We are extremely pleased with this robust and significant outcome from this trial in opioid-experienced patients and look forward to sharing more of the results from this study and the positive results from the earlier opioid-naive study at upcoming medical conferences," said Dr. Mark A. Sirgo, President and CEO of BDSI. "In addition, the locking of the database for the opioid-experienced study has triggered a $10 million milestone payment from Endo per our licensing agreement.
We look forward to working with Endo toward the completion of the NDA." "BEMA buprenorphine is an important development program for Endo," said Rajiv De Silva, President and CEO of Endo. "Our U.S. Branded Pharmaceuticals team has extensive experience supporting pain therapeutics and this program represents a significant opportunity to continue to leverage our commercial capabilities, if we are successful with our application for approval." About the Phase III BEMA buprenorphine trial in opioid-experienced patients
The Phase III clinical trial was an enriched-enrollment, double-blind, randomized withdrawal study to evaluate the efficacy and safety of BEMA buprenorphine in the treatment of chronic lower back pain in opioid-experienced patients. A total of 511 patients who titrated to a well-tolerated, effective dose were randomized to either continue on that dose of BEMA buprenorphine, or receive placebo (BEMA film with no active drug), with treatment continuing for 12 weeks. The primary efficacy endpoint was the mean change in the daily average pain numerical rating scale (NRS-Pain) scores from baseline (just prior to randomization) to week twelve of the double-blind treatment period.
Pain was self-reported daily on an 11-point numeric rating scale (daily NRS; 0=no pain, 10=worst possible pain).