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Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
Date:5/6/2008

is not required to follow the Committee's guidance, but the agency does take this advice into consideration when reviewing a proposed label expansion.

Conference Call for Investors

Cephalon management will discuss the FDA Advisory Committee proceedings with investors during a conference call beginning at 5:30 p.m. EDT today. To participate in the conference call, dial 1-913-312-0407 and refer to conference call ID number 2046179. Individual investors are encouraged to log onto the investor relations section of http://www.cephalon.com and click on the webcast to access the live call.

PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL.

Reports of serious adverse events, including deaths in patients treated with FENTORA have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of FENTORA for any other fentanyl product may result in fatal overdose.

FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer.

FENTORA is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.

FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Death
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SOURCE Cephalon, Inc.
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