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Breakthrough cancer pain, an often debilitating condition, ischaracterized by its rapid onset, moderate-to-severe intensity, and itsrelatively short duration. Research studies have demonstrated that anestimated 51-89 percent of patients with cancer who are taking around-the-clock opioid therapy for their underlying persistent pain will experiencebreakthrough pain.
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"We are committed to bring new medications to the European markets thataddress the needs of patients with cancer for effective supportive caretreatment, including pain management," said Alain Aragues, President CephalonEurope. "Cephalon continues to build its presence in Europe, the Middle Eastand Africa and activities are ongoing to make EFFENTORA available quickly inthe EU member countries."
EFFENTORA utilizes the proprietary OraVescent(R) drug delivery technologyto permit absorption of the opioid fentanyl across the inner lining of thecheek - the buccal mucosa - at a rate designed to match the onset of abreakthrough pain episode. The safety and efficacy of EFFENTORA have beenevaluated in two double-blind, randomized, placebo-controlled crossoverstudies involving a total of 248 cancer patients with breakthrough pain whoexperienced between one and four episodes of breakthrough pain per day and whowere already taking maintenance opioid therapy. An extension study hasdemonstrated safety and tolerability in 197 patients followed over a six-monthperiod.
In September 2006, the fentanyl buccal tablet formulation was approved inthe 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 in2006. In patients with cancer, chronic pain often has two components:persistent pain and breakthrough cancer pain. Breakthrough pain is an intensetransient flare of pain that interrupts or "breaks through" their persistentpain. The onset of breakthrough cancer pain is often sudden, reaches peakintensity within three minutes, and lasts for a median duration of 30 minutes.Patients may have up to four episodes of breakthrough pain per day. Episodesmay occur during a specific activity or incident or spontaneously with noapparent cause.
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceuticalcompany dedicated to the discovery, development and commercialization ofinnovative products in four core therapeutic areas: central nervous system,pain, oncology and addiction. A member of the Fortune 1000, Cephaloncurrently employs approximately 3,000 people in the United States and Europe.U.S. sites include the company's headquarters in Frazer, Pennsylvania, andoffices, laboratories or manufacturing facilities in West Chester,Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Thecompany's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenictrioxide) injection, TREANDA(R) (bendamustine hydrochloride), AMRIX(R)(cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R)(naltrexone for extended-release injectable suspension), GABITRIL(R)(tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] andACTIQ(R) (oral transmucosal fentan
