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Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ
Date:7/21/2011

ng to patients appropriate for the medications.  All stakeholders can enroll in the system any time beginning in September 2011.  There will be a transition period of about six months following launch of the REMS after which no prescription may be dispensed unless the prescriber and pharmacy are enrolled.    

Cephalon will provide regular updates to FDA regarding the effectiveness of the REMS.  Based on these evaluations, Cephalon plans to open discussions with FDA regarding the Company's pending supplemental New Drug Application for FENTORA as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.

Important Safety Information

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

Reports of serious adverse events, including deaths in patients treated with ACTIQ® 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 ACTIQ for any other fentanyl product may result in fatal overdose.

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies 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 oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

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

Life-threatening respiratory depression could occur at any dose in opioid non-tolerant pa
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SOURCE Cephalon, Inc.
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