Risk Evaluation and Mitigation Strategy program for FENTORA and ACTIQ

Cephalon, Inc. (Nasdaq: CEPH) announced that healthcare professionals, pharmacies, and distributors who prescribe and dispense FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] can enroll in the recently approved Risk Evaluation and Mitigation Strategy (REMS) program. The primary method for prescriber and pharmacy enrollment is online at www.actiqandfentorarems.com. A call center is available to provide additional support and information at 1-888-688-6885.

Under this REMS, healthcare professionals and pharmacies who prescribe and dispense FENTORA and ACTIQ enroll by completing an education module and knowledge assessment focused on safety information including appropriate patient selection. Healthcare professionals who prescribe these products are also educating patients as part of the program.

After March 20, 2012, only prescribers, pharmacies, and distributors enrolled in the program will be able to prescribe, dispense, and distribute FENTORA or ACTIQ in an outpatient setting. Only patients who have been educated about the benefits and risks of taking FENTORA or ACTIQ may receive their medication. For inpatient settings such as hospitals, patient and prescriber enrollment in the REMS is not required.

Both products are indicated for the management of breakthrough pain in opioid-tolerant patients with cancer, who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. 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 FENTORA and ACTIQ REMS is designed to provide checks and balances within the distribution channel to offer safeguards to help assure dispensing to patients appropriate for the medications.

To view safety information, click here.