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Fentanyl Buccal Tablets Ease Noncancer-Related Breakthrough Pain: Presented at AAPM By Ric Susman KISSIMMEE, FL -- February 19, 2008 -- Treatment of noncancer-related breakthrough pain was sustained through 12 weeks with use of fentanyl buccal tablets and proved more effective than placebo. In addition, the tablet was well tolerated throughout the trial, exhibiting an adverse event profile consistent with those seen in pervious short-term studies of the product, said John T. Farrar, MD, Assistant Professor of Epidemiology in Biostatistics and Epidemiology, University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States. "Significant differences in mean pain intensity were seen as early as 15 minutes postdose when compared with placebo," Dr. Farrar said at his poster presentation on February 14 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting. The primary endpoint of the study, mean sum of pain intensity differences, was 7.7 on a scale from 1 to 10 for patients taking fentanyl versus 4.6 for placebo (P < .05), Dr. Farrar reported. Patients taking fentanyl buccal tablets also achieved greater pain relief at 5 minutes, and they achieved greater meaningful pain relief at 10 minutes and at 15 minutes. Dr. Farrar and colleagues screened 199 patients and selected 148 to participate in the study. Patients were aged 18 to 80 years and all experienced noncancer-related pain for at least 3 months. The majority of patients in the study were women (62%), 94% of patients were Caucasian, and the average age was 51.5 years. Of the patients in the study, 47% were experiencing lower back pain. During the titration phase, 30% of the original total discontinued from the study due to adverse events and lack of drug efficacy, Dr. Farrar said. The most common adverse events were nausea, dizziness, and somnolence; no deaths occurred during the study, but serious adverse events occurred in 7% of patients. Dr. Farrar said 10% discontinued the study due to adverse events. "This study used a novel design, which is the first to assess the treatment of breakthrough pain over a 12-week evaluation period." Dr. Farrar said. "This was the first 12-week study to show efficacy of a treatment for noncancer-related breakthrough pain." Funding for the study was provided by Cephalon, Inc. [Presentation title: Fentanyl Buccal Tablet in Opioid-Tolerant Patients With Non-Cancer-Related Breakthrough Pain on Around-the-Clock Opioids: a 12-Week Study Using a Novel Double-Blind, Placebo-Controlled Design. Abstract 130] E-mail this page to a friend or colleague! To print, use this version