To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Tramadol Receives Expanded Indication in Canada for Moderately Severe Pain URL: http://www.pslgroup.com/dg/229DDE.htm Doctor's Guide August 25, 2008
NEW YORK -- August 25, 2008 -- The Therapeutic Products Directorate (TPD) in Canada has approved an expanded indication for once-daily tramadol (Ralivia) to include the treatment of moderately severe pain in addition to moderate pain. The new indication is based on the results of 4 randomised, double-blind, parallel-group, placebo-controlled trials involving more than 3,000 patients and lasting 12 weeks. An additional study confirmed the safety and efficacy of tramadol administered for up to 58 weeks. All participants of the trials presented with persistent, moderate-to-severe pain due to osteoarthritis of the knee and/or hip and low back pain. Results showed that tramadol produced significant reductions in pain intensity relative to placebo as early as the first day of treatment, with analgesic efficacy increasing throughout the first 4 weeks of treatment. Tramadol also produced significant improvements in sleep, including improvements in sleep quality, trouble falling asleep, and awakening by pain at night and in the morning. Side effects include dizziness, nausea, constipation, and headache. Tramadol has a potential to cause psychic and physical dependence and should not be used in opioid-dependent patients. SOURCE: Biovail --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.