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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

MALVERN, Pa. and RALEIGH, N.C., Jan. 23, 2014 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP), and BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today positive top-line results from its pivotal Phase 3 efficacy study of BEMA buprenorphine in opioid- "naive" subjects. BEMA buprenorphine is being developed for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time 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<0.005) 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. Ivan Gergel, executive vice president of research and development Endo.  "And we look forward to providing additional updates in mid-2014 regarding the BEMA buprenorphine chronic pain program."

"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. Mark A. Sirgo, President and CEO of BDSI. "In addition to these positive and encouraging results, the locking of the database for the opioid naive study has triggered a $10 million milestone payment from Endo per our licensing agreement.  We will receive a similar milestone payment related to the completion of the opioid experienced study and if successful, the potential for an NDA submission by late this year."

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.

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