Agency also expects to see safety updates if Fentora is approved.
FDA has asked Cephalon to implement enhancements to the risk management program for Fentora before the agency can approve the drug for noncancer breakthrough pain. Fentora is an opioid that is already marketed as a treatment for cancer.
In its complete response letter to the sNDA, the FDA also requested routine safety updates; no additional safety or efficacy studies were requested.
Cephalon plans to put in place COVERS™, an initiative to minimize the potential risk of overdose from an opioid through appropriate patient selection. It will educate and engage physicians, patients, and pharmacists to ensure that patients prescribed Fentora are opioid-tolerant. Additionally, the company will continue to enhance its existing programs to mitigate risks associated with abuse and misuse.
In accordance with new FDA regulations, Cephalon anticipates receiving a second communication from the agency requesting that the existing Fentora Risk Minimization Action Plan be converted to incorporate the new standards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan.
“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,” says Lesley Russell, MB.Ch.B., evp and CMO at Cephalon. “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.”
Cephalon submitted the Fentora sNDA in November 2007. The application is based on data from three randomized, placebo-controlled trials in patients with chronic noncancer pain conditions and one long-term open-label safety study with a total of 941 patients. The patients in these trials were treated for up to 18 months and had a broad range of underlying chronic pain conditions including chronic low back and chronic neuropathic pain.
