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

San Antonio, TX - 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.

SOURCE: The Cephalon, Inc.