Biovail Corporation announced that the Therapeutic Products Directorate (TPD) Canada has issued a Notice of Compliance (NOC) for 100mg, 200mg and 300mg tablet strengths of Ralivia. The company's once-daily, extended-release formulation of tramadol hydrochloride indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.
Biovail Pharmaceuticals Canada (BPC), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Ralivia to health-care professionals throughout Canada. BPC anticipates launching Ralivia shortly.
"The receipt of a Notice of Compliance for once-daily Ralivia is the first important pillar in the establishment of Biovail's family of pain-management medicines in Canada," said Scott Smith, vice-president and general manager of BPC. "Ralivia is formulated using Biovail's proprietary Smartcoat technology to provide 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Therefore, Biovail believes that the availability of Ralivia will offer health-care practitioners another compelling treatment option for their patients who suffer from pain of moderate severity".
The Ralivia formulation approved by the TPD is identical to Biovail's once-daily formulation of tramadol that received approval from the United States Food and Drug Administration (FDA) in September 2005. The product, Ultram ER, was launched in the US and Puerto Rico by Ortho-McNeil, Inc., a Johnson & Johnson company, and is the only once-daily, extended-release formulation of tramadol available in the United States.
Ralivia was approved based on clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3,000 patients who received doses of up to 400mg once daily. Biovail's NDS submission also included 12 definitive and five supportive pharmacokinetic studies.