The trial, the first study of bicifadine in patients with neuropathic pain, will randomize 50 patients with painful diabetic neuropathy into two parallel four-week treatment groups.
The trial is designed to assess the efficacy and safety of bicifadine and potential interactions of bicifadine and oxycodone used concurrently. DOV expects to complete dosing in the third quarter of this year.
“Given the efficacy in preclinical neuropathic pain models and the encouraging efficacy data already collected in our open label phase III clinical trial in chronic low back pain, we believe bicifadine could address the need for improved pain control in diabetic patients with painful neuropathy,” said Dr Warren Stern, senior vice president of Drug Development.
According to Datamonitor intelligence, the neuropathic pain market has considerable unmet medical need and has been marked by the use of widely varying drug classes to treat patients. The US and EU neuropathic pain markets are estimated at a combined total of $2.5 billion in 2005 and projected to reach more than $4.1 billion by 2007.
Bicifadine is currently being evaluated in four phase III clinical trials – three in chronic low back pain, and one in patients suffering pain after vaginal hysterectomy.