BioDelivery Sciences International Responds to Approval of Class-Wide REMS for All Transmucosal Fentanyl Products

BioDelivery Sciences International, Inc.

responded to the approval and announcement by the U.S. Food and Drug Administration that a Risk Evaluation Mitigation Strategy covering all transmucosal fentanyl products has been approved. The program, which will be referred to as the Transmucosal Immediate Release Fentanyl 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.