FDA approves REMS for Fentora, Actiq

FDA has 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, manufactured by Cephalon, are indicated for management of breakthrough pain in opioid-tolerant patients with cancer.

The goals of REMS are to ensure proper patient selection, to prevent accidental exposure and inappropriate conversion between fentanyl products, and to mitigate the potential risks of misuse, abuse, addiction, and overdose. The newly approved REMS will replace the existing risk management programs for Fentora and Actiq.

Under REMS, pharmacies and healthcare professionals who prescribe Fentora and Actiq will enroll by completing an education module and knowledge assessment focused on safety information that includes appropriate patient selection. Prescribers will also educate patients as part of the program. Cephalon expects that enrollment in the REMS program will begin in September.

“The (REMS) 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,” said Lesley Russell, MB,ChB, MRCP, Cephalon’s chief medical officer.

When implemented, the REMS will provide checks and balances within the distribution channel to provide safeguards that will help ensure that the medications are appropriately dispensed to qualifying patients. All stakeholders can enroll in the system any time beginning in September.

There will be a transition period of about 6 months following the launch of 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 REMS. On the basis of these evaluations, Cephalon plans to open discussions with FDA about the company’s pending supplemental New Drug Application for Fentora as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.