Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ

Cephalon, Inc. CEPH announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. Both products are indicated for the management of breakthrough pain in opioid-tolerant patients with cancer. Under this REMS, pharmacies and healthcare professionals who prescribe FENTORA and ACTIQ will enroll by completing an education module and knowledge assessment focused on safety information including appropriate patient selection. Healthcare professionals who prescribe these products will also educate patients as part of the program. Cephalon expects that enrollment in the REMS program will begin in September 2011. The goals of the REMS are to ensure proper patient selection, to prevent accidental exposure and inappropriate conversion between fentanyl products, as well as to mitigate the potential risks of misuse, abuse, addiction, and overdose. The newly-approved REMS will replace the existing risk management programs for ACTIQ and FENTORA.