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Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain
Date:9/15/2008

TM), a first-of-its-kind initiative designed to minimize the potential risk of overdose from an opioid through appropriate patient selection. This innovative component of the FENTORA REMS program will educate and engage physicians, patients and pharmacists to assure 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.

FENTORA is currently approved for the management of breakthrough pain in opioid-tolerant patients with cancer (for full prescribing information, visit http://www.fentora.com). The FENTORA sNDA, submitted by Cephalon in November 2007, is based on data from three randomized, placebo-controlled clinical trials in patients with chronic non-cancer 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. In these trials, opioid-tolerant patients with chronic pain treated with FENTORA experienced statistically significant improvements in relief from breakthrough pain with an onset and duration of relief similar to that seen in studies of FENTORA in patients with cancer.

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The
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SOURCE Cephalon, Inc.
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