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Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Date:8/19/2007

ly well tolerated by the study participants with side effects consistent with those in the currently approved label. The company plans to present the data at a major medical meeting in the future.

About Breakthrough Pain

Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. Breakthrough pain has an average onset of three to five minutes and typically lasts 30 to 60 minutes.

About FENTORA

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, as described below in the FENTORA label, for their underlying persistent cancer pain. FENTORA incorporates a drug delivery system that generates transient changes in pH, which may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. 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. The most common (greater than or equal to 10 percent) adverse events observed in FENTORA cancer clinical trials were nausea, dizziness, vomiting, fatigue, headache, constipation, anemia, somnolence, and peripheral edema. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms. In addition, application site reactions were reported in nine percent of patients, tended to occur early on treatment, and resulted in treatment discontinuation in only two percent of patients. PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE

IMPORTANT WARNINGS IN THIS LABEL.

FENTORA contains fentanyl, an opioid agonist and a Schedul
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SOURCE Cephalon, Inc.

Copyright©2007 PR Newswire.

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