LABOPHARM RESPONDS TO APPROVABLE LETTER FOR ONCE-DAILY TRAMADOL

Labopharm has submitted a complete response to the approvable letter issued by the FDA for the company's once-daily formulation of tramadol, an opioid analgesic. Labopharm's response includes additional analysis of its existing data. In its response, Labopharm believes it has addressed all of the matters raised by the FDA in the approvable letter. Upon acceptance for review of the response, the FDA will assign a new action date under the Prescription Drug User Fee Act.

The company has also appealed the action taken by the FDA in its approvable letter utilizing the formal dispute resolution process. The process involves obtaining a formal review of an FDA decision by raising the matter with the supervisor of the employee who made the decision, according to Labopharm. If the issue is not resolved at the primary supervisory level, the applicant may request that the matter be reviewed at the next higher supervisory level.

Labopharm received the approvable letter for its once-daily formulation of tramadol in September following submission of its new drug application (NDA) in November 2005.

The NDA for once-daily tramadol included data from the company's global clinical development program including six Phase III clinical studies and 12 pharmacokinetic studies. Combined, more than 2,400 patients have been exposed to the product in clinical studies.