LABOPHARM FILES FOR ONCE-DAILY TRAMADOL IN CANADA

Labopharm announced that its new drug submission for its extended-release 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," James Howard-Tripp, the company's president and CEO, said.

Labopharm's application for its once-daily formulation of tramadol includes comprehensive data generated during the course of a global clinical development program similar to that included in the company's new drug application to the FDA.

Tramadol, an opiate analgesic, is currently available in Canada only in an immediate-release formulation of the product that combines tramadol with acetaminophen.