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|Endo and BioDelivery Sciences announce positive top-line results from the Phase III clinical trial of BEMA® buprenorphine in opioid-experienced patients with chronic pain|
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.
"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.
"BEMA buprenorphine is an important development program for
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).
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Endo International plc, Investors/Media: Blaine Davis, +353-1-669-6635, (484) 216-7158, Investors: Jonathan Neely, (484) 216-6645, Media: Brian O'Donnell, (484) 216-6726; BioDelivery Sciences International, Investors: Al Medwar, VP, Marketing and Corporate Development, (919) 582-9050, Investors: Brian Korb, Senior Vice President, The Trout Group, (646) 378-2923, Media, Susan Forman or Laura Radocaj, Dian Griesel International, 212-825-3210
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