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BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Third Quarter 2013 Financials
Date:11/12/2013

rnational (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 consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it is marketed as PAINKYL), 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 is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo.  Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 2 development.

An NDA for BUNAVAIL, a BEMA formulation of buprenorphine used in combination with naloxone, is currently under review for the maintenance treatment of opioid dependence and has a PDUFA date of June 7, 2014.

BDSI's headquarters is located in Raleigh, North Carolina.  For more information visit www.bdsi.com.

Cautionary Note on Forward-Looking Statements

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SOURCE BioDelivery Sciences International, Inc.
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