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

S in the U.S.  In March 2013, BDSI and its commercial partner Meda submitted a proposal to FDA to reintroduce ONSOLIS for the treatment of breakthrough cancer pain into the U.S. marketplace following previously reported appearance issues with the product.  If approved by FDA, the original ONSOLIS formulation may be on the market during the second-half of 2013 while stability data is collected on a newly formulated version of ONSOLIS.  These data may be submitted to FDA before the end of the year, and if approved, could allow introduction of the new formulation sometime in 2014.  
  • Exploration of potential new products and technologies.  In addition to advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals.  In addition, BDSI continues to investigate potential new products and technologies to complement and diversify its existing portfolio. 
  • 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, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology.  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.  Th
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