Fentanyl Effervescent Buccal Tablet In Europe

By fnord · Apr 2, 2007 · ·
  1. fnord


    Cephalon, Inc. (Nasdaq: CEPH) announced today that the company has filed a marketing application with the European Agency for the Evaluation of Medicinal Products (EMEA) for a fentanyl effervescent buccal tablet in Europe. In the United States, the tablet is sold under the trade name FENTORA(R) (fentanyl buccal tablet) [C-II]. If approved, the centralized filing of this application would allow Cephalon Europe to market this product in 29 European countries.

    This European submission follows the approval of FENTORA in September 2006 by the U.S. Food and Drug Administration for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. FENTORA was launched in the U.S. market in October 2006, and is the first tablet formulation of fentanyl and the first buccal tablet approved for cancer-related breakthrough pain. Cephalon is actively pursuing a clinical development program to explore additional indications for FENTORA in the United States.

    Breakthrough pain is a component of chronic pain characterized by its rapid onset, moderate to severe intensity, and relatively short duration. These transient flares of pain interrupt or "breakthrough" otherwise persistent or background pain. In patients with cancer, the onset of breakthrough pain is often sudden, reaches peak intensity within 3 minutes, and lasts for a median duration of 30 to 60 minutes.

    Patients experience an average of 4 episodes of breakthrough pain per day. Breakthrough pain may occur during a specific activity or incident, spontaneously with no apparent cause, or when the dose of the persistent pain medicine wears off.

    According to GLOBOCAN, the prevalence of cancer in Europe is approximately 2.9 million patients. An estimated 64 percent of patients with cancer treated for persistent or background pain will experience breakthrough pain.

    Cephalon, Inc.

    Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development, and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

    The company's products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]; numerous products are marketed internationally.

    Cephalon Europe

    Cephalon has a growing presence in Europe, with more than 800 of its 3,000 employees located in various countries. Cephalon's European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Two manufacturing plants are located in Mitry-Mory and Nevers, France. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries as well as Scandinavia. Cephalon Europe markets more than 30 products in four therapeutic areas: central nervous system, pain, primary care, and oncology.

    In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon Inc.'s 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, including EMEA approval of FENTORA; manufacturing development and capabilities; market prospects for its products; sales, adjusted net income and basic adjusted income per common share guidance; 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's 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 Inc. 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.

    Cephalon, Inc.

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  1. irisheyes
    Fentora is the most effective breakthrough pain medication, and should be not taken lightly, by people who have never taken fentanyl and OD'S forbid get od's. These abusers of this very necessary type of medication will prevent people who needed these types of needs from getting them in the future. As a 31 year old severe chronic pain suffer, I worry how I will make it through the next 50 years comfortably! Their are a great deal of people who have severe chronic pain, that are being under-medicated by doctors who are afraid of prescribing the necessary opioid to the people that need them. Abusers need to find a different avenue to get their high.
  2. RaverHippie
    Sounds like an acid/base reaction away from an overdose...They've gotta be making a killing off of that statistic. 4 times a day for life... for just less than 2 million people in the EU...hell of a target market...
  3. Psych0naut
    It's not less than 2 million, but 3 million people. But that's only the number of cancer patients in Europe. Those Cephalon sublingual Fentanyl tablets won't just be prescribed to cancer patients, but will most likely be prescribed to sufferers of MS, AIDS and other (eventually)fatal diseases as well. Sufferers of cluster headaches will most likely be candidates for prescriptions of Cephalon's sublingual Fentanyl tablets too. People with very severy, debilitating acute pain, and who have been on strong opioid painkillers for some while, will probaply get those Cephalon sublingual tablets prescribed to them as well. Now we're talking a much larger group of people, not just 3 million. Rather something like 15 million or more, it could just as well be 20 million people.

    In the Netherlands alone, a country of exactly 16 million inhabitants, and the toughest country regarding the prescription of strong opioid painkillers, and we already have a total of 21.75 million prescriptions for natural and semi-synthetic opioids written out, among which; 4.4 million Morphine(MS Contin, Oramorph etc.), 0.46 million Hydromorphone(Palladone), 11.15 million Oxycodone(OxyContin, OxyNorm). Then we have a total of 27.68 million prescriptions for the class of phenylpiperidinederivates, among which ; 0.2 million Pethidine, 27.48 million Fentanyl(Durogesic). Then we have 0.53 million prescriptions for the class of diphenylpropylamines. Then we have 0.35 million prescription for the class of oripavinederivates, among which Buprenorphine(Temgesic). And last, but not least. We have 17.30 million prescription for the "other opioids" class, which Tramadol(Tramal, Tramagetic) belongs to. All in all, there are a total of 67.71 million prescriptions for opioids written in the year 2006(all these number where from 2006, it takes 2 years for all the Dutch insurance companies to count the numbers of prescriptions declared by them, since all insurance companies work independently from each other. I'm pretty certain those statistice from Cephalon are a bit off, or they didn't think that broad ..
  4. Eldorhan
    This is completely stupid. With the insane amounts of idiots already abusing substances and pain medication, you're telling me they're gonna throw one of the world's most dangerous poison in their hands ?

    Stick with Paracetamol -> Codeine -> Morphine. After that it pretty much means you're very soon to die anyway...

    What's this ? Half a grain of salt ?
  5. Psych0naut
    In it's pure form, it would indeed be very dangerous, but the big advantage of pharmaceutical drugs is that they always contain exactly the amount the blister strip/wrapper or box says. Also, people who have been taking opioids for some while, and these buccal tablets are only prescribed to opioid tolerant people, than it's much less dangerous. The big danger though, is when these tablets find their way into the hands of non-tolerant people, especially ignorant ones. That could easilly kill, as has alreay been seen in often cases with Fentora buccal Fentanyl tablets.
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