DOV Pharmaceutical, Inc. has initiated a third Phase III clinical trial of bicifadine, its novel non-narcotic and non-NSAID analgesic, in patients with moderate to severe chronic lower back pain.

This pivotal clinical trial is intended to support an NDA filing for the management of chronic lower back pain. The first Phase III placebo-controlled pivotal clinical trial was initiated in September 2004 and has achieved over 50% enrolment to date. The second Phase III trial, a long-term safety study, was initiated in December 2004 and will enrol up to 1,550 patients. Accumulated data from this open label study will be reviewed at the Company's Third Annual Scientific Symposium to be held in New York City on October 28, 2005.

This newly-initiated Phase III trial is a randomized, double-blind, placebo-controlled, outpatient (600), multi-centre study assessing the efficacy and tolerability of three dose levels of bicifadine (200 mg b.i.d., 400 mg b.i.d. and 400 mg t.i.d.) over a three-month period. 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, patient and physician global evaluation of bicifadine, incidence of discontinuation due to lack of efficacy, use of rescue medication and other analgesia-related rating scales. Safety is being measured by adverse reaction occurrences, vital signs, ECGs, clinical lab tests and other measures.

Bicifadine is a chemically novel molecule with a unique profile of pharmacological activity. Its primary pharmacological action is to enhance and prolong the actions of norepinephrine and serotonin by inhibiting the transport proteins that terminate their physiological actions. Preclinical studies and clinical trials indicate that either one or a combination of these individual actions may account for the analgesic properties of bicifadine.