BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, responded to the approval and announcement by the US Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved. The programme, which will be referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Programme, 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 programme covers all marketed transmucosal fentanyl products under a single programme. BDSI believes one single programme will help to enhance patient safety while limiting the potential administrative burden on prescribers of transmucosal fentanyl products and their patients.  One common programme also ends the disparity in prescribing requirements for Onsolis (fentanyl buccal soluble film), which is commercialized in the US by Meda Pharmaceuticals, compared to other similar products. The programme 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 programme 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 programme, 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 programme 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 Programme (referred to as the FOCUS Programme) will be automatically transferred into the new TIRF REMS Access Programme.  Additionally, prescribers and patients enrolled in other individual REMS programmes will also automatically be transferred into the programme. In addition to consistency in educational materials, technological advances will simplify the process of participation and verification of program participation. The full programme is expected to be implemented in March 2012.

BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care and 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.