Labopharm Inc. has announced that its New Drug Submission (NDS) for its once-daily formulation of tramadol has been accepted for review by the Therapeutic Products Directorate of Health Canada. The NDS is subject to a targeted 300-day review period.
"It is our intention to commercialize our once-daily tramadol product in key markets globally and Canada represents a significant opportunity, "said James R Howard-Tripp, President and CEO, Labopharm Inc. "Our regulatory submission to Health Canada is based on the same strong data package upon which our New Drug Application to the US FDA was based. We are actively engaged in discussions to establish a marketing partnership for Canada."
Labopharm's NDS for its once-daily formulation of tramadol includes comprehensive data generated during the course of a global clinical development program and similar to that included in the company's New Drug Application to the US Food and Drug Administration.
Tramadol is currently available in Canada only in an immediate-release (four- to six-times daily) formulation of the product that combines tramadol with acetaminophen.
Canada is the eighth largest pharmaceutical market in the world with sales in 2005 of more than $16.6 billion. Sales of pain medications in Canada in 2005 exceeded $850 million.
Labopharm Inc. is an international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid, the company's proprietary advanced controlled-release technology. Labopharm's lead in-house product, a once-daily formulation of the analgesic tramadol, has received regulatory approval in 22 European countries.