The Food and Drug Administration (FDA) has requested in a complete response letter that Cephalon implement and demonstrate the effectiveness of the company’s proposed enhancements in their current FENTORA(R) risk management program. FENTORA(R) (fentanyl buccal tablet) is a treatment for opioid–tolerant cancer patients is currently approved for the management of breakthrough pain.

Cephalon has been working to implement the enhancements they presented at the FDA Advisory board meeting on May 6, 2008. The agency also requested carrying out of routine safety checks, but no additional safety or efficacy studies were requested. Furthermore, the company anticipates a second letter from the agency requesting that they incorporate the new standards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan to their FENTORA Risk Minimization Action Plan (RiskMAP). The company plans to implement COVERS(TM), designed to minimize the potential risk of overdose from opioids through appropriate patient selection. This component of the FENTORA REMS program will educate and engage physicians, patients and pharmacists to assure that patients prescribed FENTORA(R) are opioid-tolerant. Additionally, the company will continue to enhance its existing programs to mitigate risks associated with abuse and misuse.

FENTORA(R) has shown to significantly improve breakthrough pain levels in patients in three randomized, placebo-controlled clinical trials and one long-term open-label safety study. The FENTORA(R) sNDA was submitted by Cephalon in November 2007.

Cephalon, in addition to FENTORA, produces TREANDA, AMRIX and VIVITROL, among others.

SOURCE: Cephalon, Inc.