Cephalon Submits Supplemental New Drug Application for FENTORA

Monday, November 12, 2007 General News
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FRAZER, Pa., Nov. 12 Cephalon, Inc.(Nasdaq: CEPH) today announced it has submitted a supplemental New DrugApplication (sNDA) to the U.S. Food and Drug Administration (FDA) seekingapproval to market FENTORA(R) (fentanyl buccal tablet) [C-II] for themanagement of breakthrough pain in opioid tolerant patients with chronic painconditions. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity, and relatively short duration. According to a studypublished in the August 2006 issue of The Journal of Pain, up to 74 percent ofpatients with non-cancer chronic pain conditions treated for persistent pain,such as chronic low back and chronic neuropathic pain, will experiencebreakthrough pain. Currently FENTORA is approved for the management ofbreakthrough pain in patients with cancer who are already receiving and whoare tolerant to opioid therapy for their underlying persistent pain.

"The clinical trials supporting this submission mark the first time a painmedication has been evaluated as a treatment for breakthrough pain associatedwith serious chronic pain conditions other than cancer," said Dr. LesleyRussell, Executive Vice President, Worldwide Medical and RegulatoryOperations. "We look forward to working with FDA to broaden the use ofFENTORA to opioid tolerant patients with unresolved debilitating breakthroughpain."

The FENTORA sNDA includes data from three randomized, placebo-controlledclinical trials and one long-term open-label safety study with a total of 941opioid tolerant patients. The patients in the FENTORA sNDA trials weretreated for up to 18 months and had a broad range of underlying chronic painconditions, including chronic low back and chronic neuropathic pain. In therandomized clinical trials, opioid tolerant patients with chronic pain treatedwith FENTORA experienced statistically significant improvements in relief frombreakthrough pain with an onset and duration of relief similar to that seen instudies of FENTORA in patients with cancer pain. The FDA's typical reviewperiod for a sNDA is 10 to 12 months.

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

About Breakthrough Pain

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


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

The sugar-free FENTORA tablet is placed between the cheek and gum above arear molar tooth where it remains until it dissolves. When it comes intocontact with saliva, FENTORA's delivery system generates a chemical reactionbelieved to opt

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