The product has been approved with a once-daily designation for use in a dose range from 100 to 400mg per day in the treatment of moderate to severe pain.
Approval in France allows Labopharm to initiate the mutual recognition procedure (MRP) in pursuit of regulatory approval for the remainder of the European Union countries.
“Regulatory approval of our first product is our most significant milestone to date,” said James Howard-Tripp, president and CEO of Labopharm. “With the anticipated launch of our product in the second half of this year, we are well positioned to generate our first commercial revenue.”
Together with the French regulatory authority, Labopharm has been preparing its submission to initiate the MRP process for its once-daily tramadol product. In addition, the company is working to obtain pricing and reimbursement approval in France.
Labopharm is also working closely with each of its European partners to finalize preparations for commercial launch of its product.
Labopharm has licensing and distribution partners for its once-daily formulation of tramadol with Sanofi-Aventis for France, with Hexal AG for Germany, with Gruppo Angelini for Italy, with Esteve SA for Spain and Portugal and with CSC Pharma for a group of 13 eastern European countries and Austria. Combined, the marketing partnerships cover approximately 80% of the total European market for tramadol, including four of the five largest national markets.
The company is also in active discussions with potential partners for the remaining European markets, including the UK.