03.01 ONSOLIS To Benefit From Approval Of Class-Wide REMS For All Transmucosal Fentanyl Products

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.

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 additional 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.

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