Cephalon submits supplemental new drug application for pain treatment Fentora |
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Published
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Mon, 12 Nov 2007 14:59
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NEW YORK (Thomson Financial) - Cephalon Inc. Monday said it has submitted a supplemental new drug application to the Food and Drug Administration seeking approval to market its breakthrough-pain medication Fentora for the treatment of breakthrough pain in opioid-tolerant patients with chronic pain conditions.The sNDA includes data from three clinical trials and one long-term safety study showing that patients with chronic pain conditions experienced statistically significant improvements in relief while taking Fentora, the company said.Fentora was approved by the FDA in Sept. 2006 for the treatment of pain in cancer patients.Breakthrough pain is characterized by the rapid onset of moderate-to-severe bursts of pain that are relatively short in duration.Shares of Cephalon closed at $77.26 on Friday.Christie Rizkcr/tk1COPYRIGHTCopyright Thomson Financial News Limited 2007. All rights reserved.The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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