FRAZER, Pa., Sept. 15 Cephalon, Inc.(Nasdaq: CEPH) announced today receipt of a complete response letter from theFood and Drug Administration (FDA) for its supplemental New Drug Application(sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment foropioid-tolerant patients with non-cancer breakthrough pain. In its letter,the FDA requested that Cephalon implement and demonstrate the effectiveness ofproposed enhancements to the current FENTORA risk management program. Theseenhancements are consistent with the strategies the company presented at theFDA Advisory Board meeting on May 6, 2008. The agency also requested routinesafety updates; no additional safety or efficacy studies were requested. Inaccordance with new FDA regulations, the company anticipates receiving asecond communication from the agency requesting that the FENTORA RiskMinimization Action Plan (RiskMAP) be converted to incorporate the newstandards for the Risk Evaluation and Mitigation Strategy (REMS) safety plan.
"The FDA request for revisions to the FENTORA risk management program wasexpected and over the last four months we have been working diligently toprepare for implementation of the program as soon as possible. We anticipatethat the subsequent letter from the agency will provide useful guidance tofinalize the timeline for and implementation of ongoing enhancements to therisk management program," said Dr. Lesley Russell, Executive Vice Presidentand Chief Medical Officer at Cephalon. "We intend to put into place a REMSthat we hope will not only demonstrate effectiveness for mitigating the risksassociated with FENTORA but also pave the way for a new industry standard foropioid pain medications."
To address the FDA's request in the complete response letter, Cephalonplans to implement COVERS(TM), a first-of-its-kind initiative designed tominimize the potential risk of overdose from an opioid through appropriatepatient selection. This innovative component of the FENTORA REMS program willeducate and engage physicians, patients and pharmacists to assure thatpatients prescribed FENTORA are opioid-tolerant. Additionally, the companywill continue to enhance its existing programs to mitigate risks associatedwith abuse and misuse.
FENTORA is currently approved for the management of breakthrough pain inopioid-tolerant patients with cancer (for full prescribing information, visitwww.fentora.com). The FENTORA sNDA, submitted by Cephalon in November 2007,is based on data from three randomized, placebo-controlled clinical trials inpatients with chronic non-cancer pain conditions and one long-term open-labelsafety study with a total of 941 patients. The patients in these trials weretreated for up to 18 months and had a broad range of underlying chronic painconditions, including chronic low back and chronic neuropathic pain. In thesetrials, opioid-tolerant patients with chronic pain treated with FENTORAexperienced statistically significant improvements in relief from breakthroughpain with an onset and duration of relief similar to that seen in studies ofFENTORA in patients with cancer.
Founded in 1987, Cephalon, Inc. is an international biopharmaceuticalcompany dedicated to the discovery, development and commercialization ofinnovative products in four core therapeutic areas: central nervous system,pain, oncology and addiction. A member of the Fortune 1000, Cephaloncurrently employs approximately 3,000 people in the United States and Europe.U.S. sites include the company's headquarters in Frazer, Pennsylvania, andoffices, laboratories or manufacturing facilities in West Chester,Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Thecompany's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:TREANDA(R) (bendamustine hydrochloride) for I