Labopharm Inc. has received a Notice of Compliance (NOC) from the Therapeutic Products Directorate (TPD) of Health Canada for 100 mg, 200 mg and 300 mg tablets of its once-daily formulation of tramadol for the management of pain of moderate severity in adults who require treatment for several days or more. The NOC allows the marketing and sale of Labopharm's once-daily tramadol product in Canada.
"With more than 26 million prescriptions written for pain products in 2006, the Canadian market represents an important component of our global commercialisation plan for our once-daily tramadol product," said James R Howard-Tripp, president and chief executive officer, Labopharm Inc. "We believe that our once-daily tramadol product offers physicians and patients an efficacious and safe option for treatment of pain of moderate severity, with the added benefit of once-a-day dosing."
Labopharm's New Drug Submission (NDS) to Health Canada for its once-daily formulation of tramadol included data from the company's global clinical development programme, including six phase III clinical studies in which 14 Canadian centres participated, and 12 pharmacokinetic studies. Combined, more than 2400 patients have been administered the product in clinical studies.
Labopharm is in active discussions to complete a licensing and distribution agreement for its once-daily tramadol product in Canada, under which the company will retain the right to co-promote the product to certain specialties through its own sales force. Labopharm expects the product to be launched in Canada later this year.