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Cephalon Submits Supplemental New Drug Application for FENTORA
Date:11/12/2007

ed clinical 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 pain. The FDA's typical review period for a sNDA is 10 to 12 months.

"Breakthrough pain appears to be highly prevalent in some populations with chronic non-cancer pain, and the commitment to use an opioid to manage chronic pain should be accompanied by an effort to assess and manage the breakthrough pain as well," said Dr. Russell Portenoy, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, in New York City, and a principal investigator in the FENTORA clinical trials. "New treatment options that specifically target breakthrough pain are welcome, and are likely to improve the clinician's ability to address this problem effectively."

About Breakthrough Pain

Millions of Americans suffer from chronic pain, a condition that often consists of two distinct components: persistent pain, which is pain that is continuous throughout the day, and breakthrough pain, which is a transitory flare of moderate-to-severe pain in patients with otherwise managed persistent pain. Breakthrough pain can reach peak intensity in as little as three minutes and typically lasts for 30 to 60 minutes. It may occur during a specific activity, spontaneously with no apparent cause, or when the dose of the persistent pain medicine wears off.

About FENTORA

Approved in September 2006, FENTORA is the first tablet formulation of the opioid fentanyl and the first new medication approved for the management of breakthrough pain in opioid tolerant patients with cancer since 1998. Its proprietary OraVescent(R) drug delivery system was developed by Cephalon subsidiary CIMA LABS. FENTORA is covered by patents until 2019.

The sugar-free FENTORA tablet is placed between the ch
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SOURCE Cephalon, Inc.
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