Healthcare Industry News:  Neuropathic Pain 

Biopharmaceuticals Drug Delivery

 News Release - May 4, 2006

Cephalon's Fentanyl Effervescent Buccal Tablet Reduces Intensity of Breakthrough Pain in Cancer Patients

New Drug Delivery System May Address Need for Rapid Onset of Pain Relief for this Undertreated Component of Chronic Pain

SAN ANTONIO, May 4 (HSMN NewsFeed) -- Results of a Phase 3 clinical trial demonstrate positive results with a fentanyl effervescent buccal tablet (FEBT) in all measures of pain control assessed in a chronic cancer pain population. The Cephalon, Inc. (Nasdaq: CEPH ) data were reported in a platform presentation at the annual meeting of the American Pain Society (APS). FEBT utilizes a new delivery technology designed to produce a more rapid and efficient absorption of medicine. The medication is designed to help patients with a common, yet undertreated, component of chronic pain called breakthrough pain, which is characterized by its fast onset.

"Helping patients get better control of their pain requires that clinicians adequately address breakthrough pain," said Donald Taylor, M.D., of Comprehensive Pain Care PC in Marietta, Ga., a study investigator. "For breakthrough pain, you need a medication that comes closer to matching the rapid onset of the pain episodes and has a relatively short duration of action. Based on the results of the Phase 3 clinical trials, FEBT appears to have that profile."

The investigational, sugar-free fentanyl tablet is placed between the upper cheek and the gum, where an effervescent reaction helps the active ingredient, fentanyl, dissolve and enhances the rate and extent of absorption. If approved by the U.S. Food and Drug Administration (FDA), FEBT would be the first oral buccal tablet developed specifically for the treatment of breakthrough pain in cancer patients.

The double-blind, placebo-controlled, randomized trial evaluated FEBT in chronic pain patients with cancer-related breakthrough pain. Thirty U.S. sites enrolled 123 patients with cancer who were already receiving various around-the-clock opioid medications for persistent pain, and had one to four episodes of breakthrough pain a day that were controlled with a short-acting oral opioid. After the initial dose titration phase, 72 patients completed a double-blind phase in which they were randomly assigned to one of 18 predefined dosing regimens that would expose each individual patient to both FEBT and placebo during the course of the study. Patients had the option to use their prior supplemental opioid for any breakthrough pain episode that did not respond within 30 minutes of FEBT or placebo administration.

Key study findings, include:

-- FEBT produced clinically significant decreases in pain intensity after administration . analgesic effect was apparent at the first time-point measured, 15 minutes after administration, and was sustained throughout the one-hour assessment.

-- There was significantly more pain relief reported with FEBT than placebo.

-- Mean global medication performance ratings - a measure of patient satisfaction - were higher for FEBT compared to placebo at all points of evaluation.

-- Study patients were twice as likely to require supplemental opioid medications for episodes of breakthrough pain when using the placebo dose than after receiving FEBT.

-- Adverse events associated with FEBT in the clinical trial were typical of those seen with opioids and in cancer populations being treated with chemotherapy, including nausea (22%), dizziness (22%), and headache (15%). Two patients withdrew from the study because of adverse events at the site of tablet placement.

"Cephalon was the first company to clinically study breakthrough pain, and we are developing additional treatment approaches for this often debilitating chronic pain condition," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations at Cephalon. "The data presented today at APS were pivotal to Cephalon's FDA submission last fall for the review of FEBT as a safe and effective treatment for breakthrough pain in opioid tolerant patients with cancer."

Clinical trials of FEBT also are underway with patients who are treated with opioids and who experience breakthrough pain associated with a range of chronic pain conditions, including chronic back and Neuropathic Pain. More information about these studies is available at http://www.clinicaltrials.gov.

Breakthrough Pain and its Impact

Approximately 50 million Americans suffer from chronic pain each year. Chronic pain consists of two components: persistent pain, pain that is continuous throughout the day, and breakthrough pain, transitory flares of moderate-to-severe pain in a person whose persistent pain is otherwise controlled. Breakthrough pain often goes unrecognized and inadequately treated, yet it affects large numbers of Americans who live with chronic 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.

An estimated 64 percent of all cancer patients treated for persistent pain - and up to 74 percent of patients treated for persistent pain from other conditions such as low back pain, diabetic neuropathy, and osteoarthritis - will experience breakthrough pain. The costs of breakthrough pain episodes are high for individuals, families, and society, with resulting economic impact seen in increased medical expenditures and decreased work productivity.

FEBT and the OraVescent® Technology

FEBT uses a dynamic effervescent process to alter pH levels in the mouth in order to enhance delivery of fentanyl. The effervescent reaction is triggered by the production and dissipation of carbon dioxide, which in turn causes gradual changes in pH levels. First the pH level is lowered, which allows the tablet to dissolve more rapidly and thoroughly and then the pH level rises, which increases the absorption of fentanyl across cheek and mouth (buccal) tissues. FEBT is a discrete, sugar-free buccal tablet that may be self-administered without water.

Conventional short-acting oral opioids, often used to treat breakthrough pain, typically come in pill form and are swallowed and absorbed in the gastrointestinal tract, which can take 30-45 minutes before providing onset of pain relief. In contrast, FEBT allows about half of the medicine to be absorbed directly across the buccal mucosa, a rapid and efficient way to produce clinically relevant blood levels of the medication. Fentanyl absorption across the buccal mucosa is two times faster than if the medication was swallowed.

Cephalon-Sponsored Studies to be Presented at APS

The platform presentation is scheduled for Thursday, May 4th from 2:00- 3:30 p.m. (CDT) at the Henry B. Gonzalez Convention Center at 200 East Market Street, San Antonio, Texas. In addition to the oral presentation, four posters at the APS meeting address research related to FEBT, and two others deal with pain-related issues:

-- Successful Dose Finding with Fentanyl Effervescent Buccal Tablets: Combined Results of Open-Label Titration Dose Finding. Portenoy et al. - Poster #731, Thursday, May 4, 4:30-6:00 p.m.

-- A New Tool for Assessing the Functional and Emotional Impact of Pain and Effects of Treatment: The Goal Attainment Scale. Farrar et al. - Poster #941, Thursday, May 4, 4:30-6:00 p.m.

-- Comparative Bioavailability of the Novel Fentanyl Effervescent Buccal Tablet Formulation: An Open-Label Crossover Study. Darwish et al. - Poster #730, Friday, May 5, 4:00-5:30 p.m.

-- Patients' Experience with Fentanyl Effervescent Buccal Tablets: Interim Analysis of a Long-Term, Multicenter, Open-Label Study in Cancer-Related Breakthrough Pain. Segal et al. - Poster #732, Friday, May 5, 4:00-5:30 p.m.

-- Open-Label Study of Fentanyl Effervescent Buccal Tablets in Patients with Noncancer Pain and Breakthrough Pain: Patient Preference Assessment. Webster et al. - Poster #804, Friday, May 5, 4:00-5:30 p.m.

-- Work Productivity Loss Among Those with Painful Conditions. Novak et al. - Poster #956, Friday, May 5, 4:00-5:30 p.m.

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 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.

Cephalon currently markets four proprietary products in the United States: PROVIGIL® (modafinil) tablets [C-IV], GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal fentanyl citrate) [C-II], and TRISENOX® (arsenic trioxide) injection. In addition, VIVITROL(TM) (naltrexone for extended- release suspension) was recently approved in the United States and is expected to be available in June 2006. Cephalon also markets numerous products internationally. Full prescribing information for Cephalon products in the United States is available at http://www.cephalon.com 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, including fentanyl effervescent buccal tablets and OraVescent® Technology, interpretation of clinical results, prospects for regulatory approval of our product candidates, manufacturing development and capabilities, market prospects for its products, including prospects deriving from Cephalon's commercial presence in the oncology market or otherwise as a result of building a fully integrated oncology business, 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

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