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New lower back pain drug in late-stage trials

Clinical trial for drug commenced in patients with moderate to severe chronic lower back pain.


18 September,2005: Phase III clinical trial of a new non-narcotic and non-NSAID analgesic bicifadine has been commenced in patients with moderate to severe chronic lower back pain, DOV Pharmaceutical, Inc. announced.

This newly-initiated phase III trial is a randomized, double-blind, placebo-controlled, outpatient (600), multi-center 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.

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, 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. 

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% enrollment to date. The company expects to complete enrollment of this trial by the end of 2005 and to complete dosing by March 2006. An interim futility analysis of this trial is planned for completion in the fourth quarter of 2005. The second phase III trial, a long-term safety study, was initiated in December 2004 and will enroll 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.

Bicifadine’s pharmacological action is to enhance and prolong the actions of norepinephrine and serotonin by inhibiting the transport proteins that terminate their physiological actions. While the company believes that bicifadine also possesses additional neurochemical properties that contribute to its analgesic effects, the exact nature of these other properties is under investigation. Preclinical studies and clinical trials indicate that either one or a combination of these individual actions may account for the analgesic properties of bicifadine. 

Bicifadine is not a narcotic and, in preclinical studies, it has been shown not to act at any opiate receptor. In animal models, bicifadine does not demonstrate abuse, addiction or dependence potential.

Bicifadine has demonstrated statistically significant analgesic effects in three placebo-controlled clinical trials in patients with pain following third molar dental and bunionectomy surgery, two models of moderate to severe acute pain, a company release said. 




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