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European Commission Grants Marketing Authorization on Fentanyl Buccal Tablet

FRAZER, Pa. and MAISONS-ALFORT, France, April 14 /PRNewswire-FirstCall/ -- Cephalon, Inc. (NASDAQ:CEPH) announced today that the European Commission has granted marketing authorization for EFFENTORA(TM), a buccal tablet formulation of fentanyl. EFFENTORA is indicated for the treatment of breakthrough cancer pain (BTCP) in adult patients who are already receiving maintenance opioid therapy for chronic pain. The approval allows Cephalon to market EFFENTORA in the 27 member states of the European Union (EU), as well as Iceland and Norway.

Breakthrough cancer pain, an often debilitating condition, is characterized by its rapid onset, moderate-to-severe intensity, and its relatively short duration. Research studies have demonstrated that an estimated 51-89 percent of patients with cancer who are taking around-the-clock opioid therapy for their underlying persistent pain will experience breakthrough pain.

"We are committed to bring new medications to the European markets that address the needs of patients with cancer for effective supportive care treatment, including pain management," said Alain Aragues, President Cephalon Europe. "Cephalon continues to build its presence in Europe, the Middle East and Africa and activities are ongoing to make EFFENTORA available quickly in the EU member countries."

EFFENTORA utilizes the proprietary OraVescent(R) drug delivery technology to permit absorption of the opioid fentanyl across the inner lining of the cheek - the buccal mucosa - at a rate designed to match the onset of a breakthrough pain episode. The safety and efficacy of EFFENTORA have been evaluated in two double-blind, randomized, placebo-controlled crossover studies involving a total of 248 cancer patients with breakthrough pain who experienced between one and four episodes of breakthrough pain per day and who were already taking maintenance opioid therapy. An extension study has demonstrated safety and tolerability in 197 patients followed over a six-month period.

In September 2006, the fentanyl buccal tablet formulation was approved in the United States under the trade name FENTORA(R) (fentanyl buccal tablet) [C-II].

About Breakthrough Cancer Pain
An estimated 3 million new cases of cancer were diagnosed in Europe in 2006. In patients with cancer, chronic pain often has two components: persistent pain and breakthrough cancer pain. Breakthrough pain is an intense transient flare of pain that interrupts or "breaks through" their persistent pain. The onset of breakthrough cancer pain is often sudden, reaches peak intensity within three minutes, and lasts for a median duration of 30 minutes. Patients may have up to four episodes of breakthrough pain per day. Episodes may occur during a specific activity or incident or spontaneously with no apparent cause.

Source: Cephalon, Inc.

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