An Integrated Risk Evaluation and Mitigation Strategy (REMS) for FENTORA ® (Fentanyl Buccal Tablet) and ACTIQ® (Oral Transmucosal Fentanyl Citrate)

Published Online: Friday, January 13, 2012


It is well recognized that the judicious use of opioids can facilitate effective and safe management of chronic pain. Nonetheless, the potential risks of misuse, abuse, addiction, and overdose must be considered when prescribing opioid medications. In an effort to manage the risks associated with all opioids, the US Food and Drug Administration (FDA) now requires a Risk Evaluation and Mitigation Strategy (REMS) for certain medications. A REMS is a regulatory program designed to improve the quality of medication use, and it contains components that are intended to ensure that the benefits of a medication or therapeutic class outweigh any risks.

Rapid-onset opioids, including products such as FENTORA® (fentanyl buccal tablet, Cephalon, Inc., Frazer, Pennsylvania) and ACTIQ® (oral transmucosal fentanyl citrate, or OTFC, Cephalon, Inc., Frazer, Pennsylvania), are important treatment options for opioid-tolerant patients with chronic cancer pain accompanied by breakthrough pain (BTP). Recently, the FDA adopted the more descriptive term, transmucosal immediate-release fentanyl (TIRF), for the class of rapid-onset opioids. Cephalon, Inc., is committed to maintaining access to appropriate pain management for the often debilitating effects of BTP in opioid-tolerant patients without compromising patient or public safety. Thus, Cephalon has implemented the recently FDA-approved ACTIQ and FENTORA REMS program to help mitigate potential safety concerns observed with opioids. Eventually, this approved REMS will be merged with REMS for other TIRF products.

In this supplement, we present the background to the REMS program, a brief review of BTP along with the clinical data supporting the use of FENTORA and ACTIQ in appropriate opioid-tolerant patients, and an overview of the recently approved REMS for fentanyl buccal tablet and OTFC. Health care professionals who prescribe or dispense opioids will be required to enroll in the REMS program in order to utilize these products for treatment of their patients. Although we understand that this may require additional effort for those involved in prescribing, distributing, and dispensing TIRF products, we hope that these steps will ensure that these important medications are appropriately distributed to and received by the patients who need them.

To view the full supplement, please click here or the image to the right.

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“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Updated REMS attempts to stem the flow of extended-release, long-acting opioids to addicts while ensuring patients in severe pain retain access.
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