Dov initiates new bicifadine trial in back pain

This pivotal clinical trial is intended to support a new drug application for the management of chronic lower back pain.

The randomized trial will recruit approximately 600 outpatients at various study centers to assess the efficacy and tolerability of three dose levels of bicifadine over a three-month period. Patients who complete the study will be eligible for up to one year of additional treatment in the follow-up safety study.

The primary efficacy endpoint is a change in pain severity rating as measured by the Visual Analog Scale between the start and end of treatment. Secondary endpoints include changes in measures of functional disability, patients’ global impression of change, and global evaluation of bicifadine. Safety is being measured by adverse reaction occurrences and a range of lab tests.

Dr Warren Stern, senior vice president of drug development at Dov, said, “Currently, there is no approved drug targeted specifically to this common and debilitating condition, thus creating an excellent market opportunity for our company.”

Two previously initiated phase III trials are under way, with completions targeted for 2006. Interim analyses of the trials will be undertaken later this year.