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

RALEIGH, N.C., Dec. 29, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) responded to the approval and announcement by the U.S. Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved.  The program, which will be referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, was designed to ensure informed risk-benefit decisions before initiating treatment with a transmucosal fentanyl product, and while patients are on treatment, to ensure appropriate use.

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The approved program covers all marketed transmucosal fentanyl products under a single program.  BDSI believes one single program will help to enhance patient safety while limiting the potential administrative burden on prescribers of transmucosal fentanyl products and their patients.  One common program also ends the disparity in prescribing requirements for ONSOLIS (fentanyl buccal soluble film), which is commercialized in the U.S. by Meda Pharmaceuticals, compared to other similar products.  The program was driven through a collaborative effort between companies with transmucosal fentanyl products, including our commercialization partner Meda Pharmaceuticals, and FDA.

"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "Unfortunately, companies with similar products being marketed prior to the approval of ONSOLIS were not all held to the same standard.  This resulted in a significant commercial disadvantage for ONSOLIS given the requirements of the REMS and the associated additi
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SOURCE BioDelivery Sciences International, Inc.
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