This trial is a multi-center, double-blind, placebo-controlled, four-way crossover trial designed to assess the efficacy, tolerability and pharmacokinetics of bicifadine alone and in combination with ibuprofen. Dov expects to complete dosing in the third quarter of this year.
The clinical trial is expected to enroll 60 patients with osteoarthritis of the hip or knee. Each patient will receive one week of dosing for each of the following four treatment regimens: bicifadine, ibuprofen, bicifadine plus ibuprofen, and placebo.
“Patients suffering from osteoarthritis have been impacted by the recent withdrawal of several COX-2 inhibitors and there are continuing concerns regarding the side effect profile of NSAIDs. This environment creates an even more pronounced patient need for an arthritis pain treatment that is safe and effective in chronic dosing,” said Dr Warren Stern, senior vice president of Drug Development.
Bicifadine is also being evaluated in a number of other pain causing conditions including chronic lower back pain and neuropathic pain.