Biovail Corporation 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 (TPD) in Canada. Ralivia is now indicated for the management of moderate to moderately severe pain in adults who require continuous treatment for several days or more.
"This revised indication for moderately severe pain underscores the effectiveness of Ralivia in patients with moderate to moderately severe pain," said Biovail chief executive officer Bill Wells. "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."
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/or hip, and low back pain. An additional study confirmed the safety and efficacy of Ralivia administered for up to 58 weeks.
Ralivia has been shown to produce significant reductions in pain intensity relative to placebo as early as the first day of treatment, with analgesic efficacy increasing throughout the first four weeks of treatment. Ralivia has also been shown to produce significant improvements in sleep, including improvements in sleep quality, trouble falling asleep, and awakening by pain at night and in the morning.
Ralivia is the only once-daily tramadol formulation that has also been approved by the United States Food and Drug Administration (FDA), and the only one with over 2.5 years of US patient experience, during which time approximately 2.6 million prescriptions have been written.
Biovail Corporation is a specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products. The company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets.