FDA approves Cephalon's REMS for FENTORA, ACTIQ

Cephalon, Inc. (Nasdaq: 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) and ACTIQ® (oral transmucosal fentanyl citrate).  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.  

"The FENTORA and ACTIQ REMS demonstrate Cephalon's commitment to patient safety while maintaining access to these medicines for the often debilitating breakthrough pain experienced by many opioid-tolerant patients with cancer," said Dr. Lesley Russell, Chief Medical Officer, Cephalon. "The program provides education and systems to support safe use of FENTORA and ACTIQ, preserving availability of the medicines to patients through retail pharmacies and using other systems already familiar to prescribers and pharmacists."

When implemented, the FENTORA and ACTIQ REMS will provide checks and balances within the distribution channel to provide safeguards to help assure dispensing to patients appropriate for the medications.  All stakeholders can enroll in the system any time beginning in September 2011.  There will be a transition period of about six months following launch of the REMS after which no prescription may be dispensed unless the prescriber and pharmacy are enrolled.    

Cephalon will provide regular updates to FDA regarding the effectiveness of the REMS.  Based on these evaluations, Cephalon plans to open discussions with FDA regarding the Company's pending supplemental New Drug Application for FENTORA as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.