Biovail Corporation announced that Ralivia, the company's once-daily tramadol formulation, has been officially launched in Canada, and is now commercially available. Ralivia is indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.
The features and benefits of Ralivia, which received a Notice of Compliance from the Therapeutic Products Directorate on August 31, are being introduced to health-care professionals throughout the country by Biovail Pharmaceuticals Canada, the company's Canadian sales and marketing division.
"For patients with chronic pain, Ralivia provides comparable efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors without the long-term cardiovascular and gastrointestinal risks associated with their continuous use," said Scott Smith, vice-president and general manager, BPC. "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 20 months of US patient experience, during which time approximately 1.6 million prescriptions have been written. Further, Ralivia is the only tramadol formulation indicated for continuous use."
Ralivia, which is available in 100 mg, 200 mg and 300 mg dosage strengths, is produced using the company's proprietary Smartcoat technology, which provides 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Ralivia is identical to Biovail's once-daily tramadol formulation that was approved in September 2005 by the US FDA. That product, Ultram ER, was launched in the US and Puerto Rico in February 2006 by Ortho-McNeil, Inc., a Johnson & Johnson company, and to date is the only once-daily tramadol in the US
In clinical trials, Ralivia was studied in more than 3,000 patients with chronic, moderate-to-severe pain due to osteoarthritis of the knee and/or hip, and low back pain, in four 12-week, randomised, double-blind, parallel-group, placebo-controlled trials. 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 in approximately 60 per cent of patients, including improvements in sleep quality, trouble falling asleep, and awakening by pain at night and in the morning.
Patients who are prescribed Ralivia may experience side effects, including dizziness, nausea, constipation and headache. These side effects are most likely to present shortly after the commencement of treatment. Patients in whom these side effects persist should contact their doctor immediately.