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Cephalon Submits Supplemental New Drug Application for FENTORA
Date:11/12/2007

eek 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
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SOURCE Cephalon, Inc.
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