Biovail’s pain drug formulation approved in Canada

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.

Scott Smith, vice-president and general manager of BPC, said: “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 Therapeutic Products Directorate of Canada is identical to Biovail’s once-daily formulation of tramadol that received approval from the FDA in September 2005. Ralivia was approved based on clinical and safety data obtained from four original 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.