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Cephalon Submits Supplemental New Drug Application for FENTORA

Indication Sought for Breakthrough Pain Associated with Chronic Pain

Conditions in Patients Who are Already Taking Opioid Medications


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

"The clinical trials supporting this submission mark the first time a pain medication has been evaluated as a treatment for breakthrough pain associated with serious chronic pain conditions other than cancer," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We look forward to working with FDA to broaden the use of FENTORA to opioid tolerant patients with unresolved debilitating breakthrough pain."

The FENTORA sNDA includes data from three randomized, placebo-controlled clinical trials and one long-term open-label safety study with a total of 941 opioid tolerant patients. The patients in the FENTORA sNDA trials were treated for up to 18 months and had a broad range of underlying chronic pain conditions, including chronic low back and chronic neuropathic pain. In the randomized 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.


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 cheek and gum above a rear molar tooth where it remains until it dissolves. When it comes into contact with saliva, FENTORA's delivery system generates a chemical reaction believed to optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the upper check, or buccal mucosa. With FENTORA's drug delivery technology, approximately half of the medicine is absorbed directly across the lining of the upper cheek and into the bloodstream. Conventional short-acting oral opioids, often used to treat breakthrough pain, are swallowed and must first be absorbed in the gastrointestinal tract, which can take up to 30-45 minutes to reach effect.

In clinical trials, FENTORA was generally well tolerated. Most adverse events occurring with FENTORA are typical opioid side effects. The most serious adverse events associated with all opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. Opioid side effects should be expected and managed accordingly. The most common (greater or equal to 10 percent) adverse events observed in clinical trials of FENTORA in patients with cancer were nausea, vomiting, application site abnormalities, fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and headache. In clinical trials in patients with other chronic pain conditions, the most common (greater or equal to 10 percent) adverse events were nausea, vomiting, back pain, dizziness, headache, and somnolence. Application site adverse events were reported in 12 percent of patients. Most side effects were mild to moderate in severity. No attempt was made to correct for concomitant use of around- the-clock opioids or cancer-related symptoms.

Post-marketing reports of serious adverse events, including deaths in patients treated with FENTORA, have been reported. Deaths occurred as a result of improper patient selection and/or improper dosing. FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in patients not regularly taking around-the-clock opioids. The label for FENTORA is currently being updated to reflect these and other important safety considerations. PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE


FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid nontolerant patients.

Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children. (See Information for Patients and Caregivers for disposal instructions.)

Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg per mcg basis. Adjust doses as appropriate. (See DOSAGE AND ADMINISTRATION.)

FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

Full prescribing information about FENTORA, including boxed warning, is available from

About Cephalon, Inc.

Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered a seven-year compound annual growth rate (CAGR) through 2006 greater than 75% and 2006 revenue of $1.760 billion. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. 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. Cephalon'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) (arsenic trioxide) injection, AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at or by calling 1-800-896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon'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 including the FENTORA clinical trials discussed herein; prospects for regulatory approval, including approval of the FENTORA sNDA and the timing of the FDA's review period for this submission; manufacturing development and capabilities; market prospects for its products; sales and earnings 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 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.

SOURCE Cephalon, Inc.
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