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ONSOLIS to Benefit from Approval of Class-Wide REMS for All Transmucosal Fentanyl Products
Date:12/29/2011

onal steps required by healthcare providers and their patients."   

Dr. Sirgo continued, "We are very pleased to see the approval of a class-wide REMS program, which we believe will not only mean a level competitive environment, but also the potential for expanded access to ONSOLIS through availability in retail pharmacies.  With the implementation of a class-wide REMS program late in the first quarter of 2012 by Meda Pharmaceuticals, ONSOLIS can finally compete on its own merits."

Healthcare professionals and patients with active enrollment in the ONSOLIS REMS Program (referred to as the FOCUS Program) will be automatically transferred into the new TIRF REMS Access Program.  Additionally, prescribers and patients enrolled in other individual REMS programs will also automatically be transferred into the program.  In addition to consistency in educational materials, technological advances will simplify the process of participation and verification of program participation.  The full program is expected to be implemented in March 2012.

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 oncology supportive care.  BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer.  T
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SOURCE BioDelivery Sciences International, Inc.
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