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Cephalon Presents Positive Results for Fentora in Breakthrough Pain,,,Associated with Neuropathic Conditions

pain intensity (PI) and pain relief (PR) was significantly greater with FENTORA than placebo at 10 minutes (p<0.05, p=0.0005, respectively) and maintained throughout the 120 minute evaluation period (p<0.0001 for both PI and PR). -- Significantly more episodes treated with FENTORA showed clinically meaningful reductions in pain intensity (greater or equal to 33 percent reduction at 10 minutes, p=0.008; greater or equal to 50 percent improvement at 15 minutes, p=0.0057). These improvements persisted throughout the 120 minute measurement period (p<0.0001). -- The majority of patients preferred FENTORA over their previous breakthrough pain treatment, rating it good or excellent with respect to onset of action (72 percent), ease of administration (78 percent), and convenience of use (79 percent). -- FENTORA was generally well-tolerated. Adverse events associated with FENTORA in the clinical trial were typical of those seen with opioids, with the exception of mild and transitory application site abnormalities (8 percent). The most common side effects included nausea (13 percent), dizziness (13 percent), drowsiness (10 percent), and vomiting (5 percent). Of the 102 patients included in the safety evaluation, 12 withdrew from the study due to adverse events during the titration phase; none were due to application site abnormalities. There were no reports of respiratory depression or other serious adverse events related to FENTORA in this study.

"This study shows the important role FENTORA can play in the management of breakthrough pain in patients with neuropathic conditions who are already receiving opioids for their persistent pain," said Dr. Lesley Russell, Executive Vice President, Worldwide
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