Dov Pharmaceutical Inc announced initiation of a Phase III clinical trial investigating bicifadine, the Company's novel, non-narcotic analgesic, in the treatment of moderate to severe post-surgical dental pain.

This confirmatory Phase III study is a double blind, placebo-controlled, pivotal trial that compares bicifadine and tramadol to placebo using as a primary endpoint measure the Summed Pain Relief and Intensity Difference (SPRID) score, a measurement tool that reflects the total analgesia produced over the entire test period.

"In August 2002, we announced positive phase II results for bicifadine, showing it to be an effective analgesic as compared to placebo, with an efficacy at least equivalent to codeine in reducing moderate to severe dental pain. We are very encouraged by the clinical study results to date for bicifadine and look forward to the findings from this phase III study," said Dr. Bernard Beer, President of DOV.

Bicifadine is a chemically distinct molecule with a unique profile of pharmacological activity. It has two primary biochemical actions. It enhances and prolongs the actions of norepinephrine and serotonin, neurotransmitters associated with analgesia, by inhibiting the transport proteins that terminate their physiological actions. In addition, bicifadine interferes with the ability of glutamate to stimulate calcium entry into neurons. This type of calcium blockage has also been associated with analgesia. Preclinical and clinical studies indicate that either of these actions, or a combination, may account for the analgesic properties of bicifadine.

Bicifadine has been shown not to act at any opiate receptor and therefore is not a narcotic. In animal models, bicifadine did not demonstrate abuse, addiction, or dependence potential. Bicifadine development prior to this study included seven Phase I clinical trials, and 15 Phase II clinical trials, involving over 1700 patients. DOV conducts a joint venture partnership with Elan Corporation plc to develop controlled release formulations of bicifadine for the treatment of pain.