RxTrials Institute Drug Pipeline Alert

Canadian drugmaker Labopharm has requested a meeting with the FDA regarding the company’s new drug application (NDA) for its once-daily formulation of tramadol, a treatment for moderate-to-severe pain.

Based on data from the company’s global clinical trial program submitted with the NDA, Labopharm believed it provided the agency with enough evidence of the efficacy and safety of the drug.

Labopharm’s NDA for once-daily tramadol included data from the company’s global clinical development program, which included six Phase III clinical studies and 12 pharmacokinetic studies, according to the company.