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Endo Health Solutions Inc's Subsidiary And BioDelivery Sciences International Inc Provide Update On BEMA Buprenorphine Phase III Development Program


Wednesday, 4 Sep 2013 06:00am EDT 

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc and BioDelivery Sciences International, Inc announced that the companies have completed interim analyses of both the opioid naive and opioid experienced Phase III trials for BEMA Buprenorphine. The interim analyses were conducted as part of the Phase III protocol to allow for adjustments to the sample size in order to maintain appropriate study power to detect statistically differences between BEMA Buprenorphine and placebo. The analyses were conducted by an independent biostatistician. Endo and BDSI view the outcomes of the interim analyses as encouraging. As a result of the interim analyses, it was determined that no sample size adjustment will be necessary to the opioid naive study. Additional patients will be added to the ongoing opioid experienced trial to maintain appropriate power to allow for the detection of a statistically difference between BEMA Buprenorphine and placebo based on the primary efficacy endpoint. 

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