FRAZER, Pa., Oct. 11 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that data from a Phase 3 clinical trial of FENTORA(TM) (fentanyl buccal tablet) [C-II] demonstrate efficacy in the management of breakthrough pain in opioid-tolerant patients with chronic low back pain.
In the double-blind, placebo-controlled study, statistically significant differences in pain intensity were apparent within 10 minutes (p<0.02) and at all subsequent time points measured throughout the 120 minute assessment period (p<0.0001). Improvement as measured on the primary endpoint (the Sum of Pain Intensity Differences at 60 minutes, SPID60) was also significant (p<0.0001). Adverse events were typical for opioids and more frequent during the titration phase than the double-blind phase. Data from the Cephalon- sponsored study will be presented at upcoming medical meetings, including a poster presentation at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine, November 16-19, 2006, in San Francisco.
“The results of this study suggest that FENTORA may have application beyond its current indication in cancer and provide important support to our strategy for future label expansion in breakthrough pain associated with multiple chronic pain conditions,” said Dr. Lesley Russell, Senior Vice President, Worldwide Medical and Regulatory Operations. “In opioid-tolerant patients, we believe FENTORA has the potential to address the rapid onset characteristic of breakthrough pain, a common component of low back pain.” An estimated 51 percent of people with chronic pain report back pain, making it the most common chronic pain condition, according to the American Chronic Pain Association.
FENTORA
FENTORA was approved by the Food and Drug Administration on September 25, 2006, 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. Its drug delivery system generates a reaction that is accompanied by transient changes in pH believed to optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. In clinical trials involving patients with cancer, FENTORA was generally well tolerated; most adverse events with FENTORA are typical opioid side effects and mild to moderate in severity. The most common (greater than or equal to 10%) adverse events observed in clinical trials of FENTORA were nausea, vomiting, application site abnormalities, fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and headache. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms. 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.
Breakthrough Pain
Breakthrough pain - a component of chronic pain - is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain. Breakthrough pain can reach peak intensity in as little as three minutes and typically lasts for 30 to 60 minutes. An estimated 64 percent of all cancer patients treated for persistent pain - and an estimated 74 percent of patients treated for persistent pain from other chronic pain conditions - will experience breakthrough pain.
IMPORTANT WARNINGS AND SAFETY INFORMATION
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 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 non-tolerant 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 Their Caregivers contained within the prescribing information 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 and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
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.
Full prescribing information about FENTORA, including boxed warning, is available from http://www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855) 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.
The company currently markets six proprietary products in the United States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II], and numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
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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 any future indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients with chronic low back pain; prospects for regulatory approval; market prospects for its product; 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.
Cephalon, Inc.
CONTACT: Investor Contact: Chip Merritt, +1-610-738-6376 (office),cmerritt@cephalon.com, or Media Contact: Stacey Beckhardt, +1-610-738-6198(office), sbeckhar@cephalon.com, both of Cephalon
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