FDA Approves REMS for Actiq and Fentora

The FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl buccal tablet) and Actiq (oral transmucosal fentanyl citrate), two products from Cephalon, Inc. that are indicated for the management of breakthrough pain in opioid-tolerant patients with cancer.

Under the REMS, pharmacies and health care professionals who prescribe Fentora and Actiq will enroll by completing an education module and knowledge assessment focused on safety information including appropriate patient selection. As part of the program, those who prescribe these products will also educate patients. Cephalon expects enrollment in the REMS program to 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 program, Lesley Russell, MD, Cephalon’s chief medical officer, is designed to provide "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 is designed to provide checks and balances within the distribution channel to provide safeguards to help assure dispensing to patients appropriate for the medications. According to the company, there will be a transition period of about 6 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.

For safety information on both drugs, which includes indications, contraindications, dispensing information, special instructions, and patient counseling guidelines, please click here.

For full prescribing information, including boxed warning, visit www.actiq.com and www.Fentora.com.