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Endo and BioDelivery Sciences Provide Update on BEMA Buprenorphine Phase III Development Program
Date:9/4/2013

ificant because they utilized actual study data to confirm or adjust sample sizes, and importantly, maintain probability of a successful outcome," said Dr. Mark A. Sirgo, President and CEO of BDSI. "Data from the opioid naive study appear consistent with our original assumptions and no additional patients are required. This study has completed patient enrollment, and we continue to anticipate the study results early next year. We expect that the additional patients required for the opioid experienced trial will result in a slight adjustment to the timing for the completion of that study to mid 2014.  While no major impact is anticipated for the timing of the NDA submission, which was scheduled for the second half of 2014, more definitive timing will be provided when patient enrollment is completed."

About Endo

Endo Health Solutions Inc. (Endo) is a U.S.-based specialty healthcare company with four distinct business segments that are focused on branded and generic pharmaceuticals, devices and services, each providing quality products to our customers while improving the lives of patients. Through our operating companies – AMS, Endo Pharmaceuticals, HealthTronics and Qualitest – Endo is dedicated to finding solutions for the unmet needs of patients. Learn more at www.endo.com.

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.

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SOURCE Endo Pharmaceuticals Inc.; BioDelivery Sciences International, Inc.
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