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news.Biovail has received an expanded indication for once-daily Ralivia - to include the treatment of moderately severe pain in addition to moderate pain - from the Therapeutic Products Directorate in Canada.
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Ralivia is now indicated for the management of moderate to moderately severe pain in adults who require continuous treatment for several days or more.
The new indication is based on the results of four 12-week, randomized, double-blind, parallel-group, placebo-controlled trials with Ralivia in more than 3,000 patients with persistent, moderate-to-severe pain due to osteoarthritis of the knee and hip, and low back pain. An additional study confirmed the safety and efficacy of Ralivia administered for up to 58 weeks.
Bill Wells, CEO of Biovail, said: “Ralivia provides an analgesic option for patients with moderate to moderately severe pain without the risk of long-term cardiovascular and gastrointestinal risks that are associated with non-steroidal anti-inflammatory drugs and COX-2 inhibitors.”