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| |  Fentanyl Buccal Tablets Appear Safe and Tolerable for Cancer Breakthrough Pain: Presented at AAPM By Ed Susman KISSIMMEE, FL -- February 18, 2008 -- Doctors said that fentanyl buccal tablets (Fentora) that rapidly dissolve in the pocket of the cheek are safe -- and preferred -- by opioid-tolerant cancer patients who experience breakthrough pain. "These tiny tablets are easy to use and require a minimum of saliva in the mouth to dissolve," said Sharon Weinstein, MD, Professor of Anaesthesiology, University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States, during the American Academy of Pain Medicine (AAPM) 24th Annual Meeting. "Breakthrough pain, a transitory moderate to severe exacerbation of pain, occurs in about 60% to 90% of opioid-tolerant patients with chronic, persistent, cancer-related pain that is generally otherwise controlled," Dr. Weinstein said in her poster presentation on February 15. In patients who have cancer, quick-acting analgesics require suitable amounts of saliva to get the medicine into the body and to protect tissues, she explained. Since cancer patients -- especially those with head and neck cancers -- often have a lack of saliva, that requirement makes the fentanyl buccal tablets more attractive than other means of combating breakthrough pain, such as the fentanyl lollipop, she said. In their open-label study, Dr. Weinstein and colleagues enrolled 232 patients, including 120 patients who were rolled over from previous studies of the tablet and reported having 1 to 4 episodes of breakthrough pain per day. Patients were first titrated to determine their individual tolerated dose of the drug and then were entered into the maintenance phase of the trial, in which each patient took their successful dose as needed to obtain relief of breakthrough pain, up to a maximum of 8 tablets per day. Adverse events increased with higher doses of the drug, but no serious adverse effect was attributed to the medication except for 1 patient who experienced drug withdrawal syndrome. Patients' responses on a questionnaire of their experiences with fentanyl buccal tablets showed that about 87% preferred the treatment to their previous breakthrough pain medication, compared with 13% who preferred their original medication. Among those who preferred the fentanyl buccal tablets, about 90% said the time to onset of pain relief was faster than their previous medication, compared with 10% of patients who preferred their original medication. About 60% of patients who preferred using fentanyl buccal tablets said they were more convenient to use, compared with 40% of patients who preferred their previous treatments for breakthrough pain. "The initial successful dose of fentanyl buccal tablet was generally maintained and was the same as the first dose for the majority of the patients in this study after 1 year," said Dr. Weinstein. Funding for this study was provided by Cephalon, Inc.
[Presentation title: Long-Term Safety of Fentanyl Buccal Tablet for the Treatment of Breakthrough Pain in Opioid-Tolerant Cancer Patients. Abstract 119]
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