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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of First Quarter 2013 Financials
Date:5/9/2013

orphine, toward key milestones, while executing an exciting licensing agreement for Clonidine Topical Gel to extend our pipeline of products in pain," said Dr. Mark A. Sirgo , President and Chief Executive Officer of BDSI.  "We are excited about the potential of our product portfolio and are committed to working aggressively toward our primary objective of filing the NDA for BUNAVAIL in mid-summer."   

Anticipated 2013 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

  • Submission of BUNAVAIL NDA for opioid dependence.  Based on demonstrating bioequivalence in the pivotal pharmacokinetic study and positive results in the safety study, BDSI anticipates it will submit an NDA to the FDA for BUNAVAIL in mid-summer 2013.
  • BUNAVAIL commercialization opportunities.  BDSI will continue to evaluate its strategic options for the commercialization of BUNAVAIL, which include partnership, internal approaches or a combination of these.  BDSI expects to finalize its strategy in the second half of 2013.
  • Recruitment of two Phase 3 studies for BEMA Buprenorphine.  BDSI and Endo expect to continue recruitment in the two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups.  The trials are expected to complete in late 2013 or early 2014.  Upon completion of study enrollment and database lock for each trial, and the acceptance of filing of the NDA with the FDA, BDSI is expected to receive milestone payments from Endo totaling $30 million. 
  • Commence Confirmatory Study for Clonidine Topical Gel.  BDSI plans to prepare for a confirmatory study in the latter part of 2013 which could lead to data availability by the end of 2014.
  • Re-introduction of ONSOLI
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SOURCE BioDelivery Sciences International, Inc.
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