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Tramadol Receives Expanded Indication in Canada for Moderately Severe Pain 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 E-mail this page to a friend or colleague! To print, use this version