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Advisory Committee Votes Not to Approve Expanded Label for Fentanyl Buccal Tablet

May 8, 2008 -- Cephalon, Inc. (Nasdaq: CEPH) announced today that a Joint Advisory Committee to the U.S. Food and Drug Administration (FDA) voted not to recommend approval of an expanded label for FENTORA(R) (fentanyl buccal tablet) [C-II] for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions. The panel expressed concerns about minimizing risks potentially associated with an expanded indication of FENTORA. During the meeting, the company presented a comprehensive and novel Risk Minimization Action Plan (RiskMAP) to address these risks.

FDA action on the FENTORA supplemental new drug application (sNDA) is expected by September 13, 2008. FENTORA is currently indicated for the management of breakthrough pain in opioid-tolerant patients with cancer.

"We are disappointed with the recommendation of the Advisory Committee," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations at Cephalon. "We will work with the FDA over the next few months to determine future steps including any additional risk minimization strategies that could potentially address the panel's concerns in this broader patient population."

The recommendation of the Joint Advisory Committee for Anesthetic and Life Support Drugs and the Advisory Committee for Drug Safety and Risk Management was based upon data presented by Cephalon from three randomized clinical trials and one 18-month open-label safety study with a total of 941 patients. The Joint Advisory Committee also considered proposed enhancements to the FENTORA RiskMAP that are designed to assure appropriate patient selection and to mitigate the risks of overdose, abuse, and diversion.

The FDA considers the Committee's recommendation in its review of the sNDA for FENTORA, which was submitted by Cephalon in November 2007. The FDA is not required to follow the Committee's guidance, but the agency does take this advice into consideration when reviewing a proposed label expansion.

Source: Cephalon, Inc.

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