Endo, BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Program
Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (NASDAQ: ENDP), and BioDelivery Sciences International, Inc. (NSDAQ: BDSI) announced today 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 significant 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 significant difference between BEMA Buprenorphine and placebo based on the primary efficacy endpoint.
"We are encouraged by the outcomes of the interim analyses which were conducted to determine if the original sample size assumptions were appropriate and to allow for adjustments to the study sample size