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BioDelivery Sciences Provides an Update of Anticipated 2014 Milestones
Date:1/10/2014

to the results of our two Phase 3 studies for BEMA Buprenorphine for the treatment of chronic pain, which could potentially lead to an NDA submission late this year.  We are also extremely excited about the prospects of an NDA approval for BUNAVAIL this coming June with a launch shortly thereafter.  Finally, initiating enrollment in our Phase 3 program for Clonidine Topical Gel for the treatment of painful diabetic neuropathy this quarter gives us our third exciting potential entry into the pain space."

Dr. Sirgo concluded, "Overall, this coming year will be an exceptionally exciting one for BDSI, and we look forward to the forthcoming milestones, which will be instrumental in enhancing the future value of the company."

Anticipated 2014 Milestones

BDSI expects to achieve the following key milestones in the upcoming year:

  • BEMA Buprenorphine Phase 3 data and additional milestone payments from Endo. In addition to the aforementioned opioid naive study database lock and subsequent milestone payment, BDSI expects to receive additional milestone payments upon the database lock of the opioid experienced study and the NDA filing.  BDSI anticipates the second database lock to occur in mid-year, and the potential filing of the NDA in late 2014.
  • Ongoing review and subsequent approval of the NDA for BUNAVAIL.  BDSI expects ongoing dialogue with the FDA in the review of the NDA for BUNAVAIL for the treatment of opioid dependence.  The review of the BUNAVAIL NDA is expected to be completed by June 7, 2014. 
  • Commercialization of BUNAVAIL in the U.S.  BDSI continues to evaluate its options for the commercialization of BUNAVAIL, including both partnering options as well as potentially leading efforts internally through the use of contract resources.  
  • Initiation of Phase 3 study for Clonidine Topical Gel.&#
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SOURCE BioDelivery Sciences International, Inc.
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