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|Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ|
FRAZER, Pa., July 21, 2011 /PRNewswire via COMTEX/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. Both products are indicated for the management of breakthrough pain in opioid-tolerant patients with cancer. Under this REMS, pharmacies and healthcare professionals who prescribe FENTORA and ACTIQ will enroll by completing an education module and knowledge assessment focused on safety information including appropriate patient selection. Healthcare professionals who prescribe these products will also educate patients as part of the program. Cephalon expects that enrollment in the REMS program will begin in September 2011.
The goals of the REMS are to ensure proper patient selection, to prevent accidental exposure and inappropriate conversion between fentanyl products, as well as to mitigate the potential risks of misuse, abuse, addiction, and overdose. The newly-approved REMS will replace the existing risk management programs for ACTIQ and FENTORA.
"The FENTORA and ACTIQ REMS demonstrate Cephalon's commitment to patient safety while maintaining access to these medicines for the often debilitating breakthrough pain experienced by many opioid-tolerant patients with cancer," said Dr. Lesley Russell, Chief Medical Officer, Cephalon. "The program provides education and systems to support safe use of FENTORA and ACTIQ, preserving availability of the medicines to patients through retail pharmacies and using other systems already familiar to prescribers and pharmacists."
When implemented, the FENTORA and ACTIQ REMS will provide checks and balances within the distribution channel to provide safeguards to help assure dispensing 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.
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About Cephalon, Inc.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 180 products in more than 100 countries. More information on Cephalon and its products is available at http://www.cephalon.com/.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide the Cephalon current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon, such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE Cephalon, Inc.
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