FDA OKs REMS for Fentora, Actiq

FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

Under the REMS, healthcare professionals who prescribe the drugs and pharmacies that dispense them will enroll by completing an education module and knowledge assessment focused on safety information and appropriate patient selection, and prescribers will educate patients.

“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,” Cephalon chief medical officer Lesley Russell said. “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.”