In its letter to the company, the FDA indicated that Labopharm’s once-daily formulation of tramadol is approvable subject to clearing up some deficiencies in the application, which Labopharm has not disclosed.
The Canadian drug company has said that it will discuss the letter with the FDA as soon as possible and believes that it can address the issues raised in the letter without the need for additional data. Labopharm added that potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data, however.
Labopharm’s new drug application for its once-daily formulation of tramadol was submitted to the FDA in November 2005. The application included data from the company’s global clinical development program including six phase III clinical studies and 12 pharmacokinetic studies.
Tramadol is an analgesic formulation used for the treatment of pain. The drug has been approved by European health authorities.