Delay for Cephalon's Fentora sNDA

US drugmaker Cephalon has received a complete response letter for its supplemental New Drug Application for Fentora (fentanyl buccal tablet) as a treatment for opioid-tolerant patients with non-cancer breakthrough pain from the Food and Drug Administration.

The FDA has requested enhancements to the firm's risk management program, although no additional safety or efficacy studies are required. Cephalon plans to implement COVERS, an initiative designed to minimize the potential risk of overdose from an opioid through appropriate patient selection. This is intended to educate physicians, patients and pharmacists to ensure that people who are prescribed Fentora are opioid-tolerant. Additionally, the company will continue to enhance its existing programs to mitigate risks associated with abuse and misuse.

"[The] FDA request for revisions to the Fentora risk management program was expected and over the last four months we have been working diligently to prepare for implementation of the program as soon as possible. We anticipate that the subsequent letter from the agency will provide useful guidance to finalize the timeline for and implementation of ongoing enhancements to the risk management program," said Lesley Russell, the company's chief medical officer.