Endo and BioDelivery Sciences Announce Positive Top-Line Results from the Phase III Clinical Trial of BEMA Buprenorphine in Opioid Naive Patients with Chronic Pain
The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.005) 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 (10% vs. 8%), vomiting (4% vs. 2%) and constipation (4% vs. 2%).
"We are encouraged by today's announced study results, which we believe are meaningful for patients suffering from moderate to severe chronic pain," said Dr.
"We are obviously pleased with the outcome from this trial in opioid naive patients and look forward to the upcoming results of the Phase 3 study for BEMA Buprenorphine for the treatment of chronic pain in opioid experienced patients," said Dr.
The second Phase 3 clinical study of BEMA Buprenorphine in an opioid "experienced" patient group is ongoing. Based on recruitment rates in this study, the database for this trial is anticipated to be locked by mid-2014, with results to follow shortly thereafter.
About the Phase 3 BEMA Buprenorphine Trial in Opioid Naive Patients
The Phase 3 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 naive patients. A total of 462 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).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's and BDSI's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in Endo's and BDSI's Form 10-K, Form 10-Q and Form 8-K filings with the
Endo Health Solutions, Inc. - Investors/Media - Blaine Davis, (484) 216-7158; Investors - Jonathan Neely, (484) 216-6645; Media - Brian O'Donnell, (484) 216-6726; BioDelivery Sciences International - Al Medwar, VP, Marketing and Corporate Development, (919) 582-9050, or Brian Korb, Senior Vice President, The Trout Group, (646) 378-2923