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

160; BDSI plans to initiate a Phase 3 study of Clonidine Topical Gel for the treatment of painful diabetic neuropathy in the first quarter of 2014.   This study could complete enrollment in late 2014.
  • Re-launch of ONSOLIS.  BDSI continues to work closely with its commercial partner, Meda Pharmaceuticals, on plans for the reintroduction of ONSOLIS into the U.S. market for the management of breakthrough pain in opioid tolerant patients with cancer.  This is anticipated to take place in the second half of 2014.
  • 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. 

    BDSI's pain franchise currently consists of three products.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.  The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).  BEMA Buprenorphine, which is licensed on a worldwide basis to Endo Pharmaceuticals, is currently in Phase 3 development for the treatment of moderate to severe chronic pain.  Clonidine Topical Gel is expected to enter Phase 3 trials in 2014 for the treatment of painful diabetic neuropathy.

    BUNAVAIL, a BEMA formulation of
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    SOURCE BioDelivery Sciences International, Inc.
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