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BY OUR PHARMA CORRESPONDENT
10 August, 2005: Phase III studies of a novel analgesic bicifadine to treat post-operative pain following vaginal hysterectomy have been commenced in the US, announced DOV Pharmaceutical, Inc in a press release.
The randomized, multi-centric (20-30 sites), parallel, placebo controlled clinical trials will have 100 patients per treatment arm (bicifadine 400 mg tid or placebo). Study medication will be administered for up to five days in patients who experience moderate to severe pain following surgery. The primary efficacy endpoints are the patients' assessment of pain intensity using a categorical scale and pain relief based on changes in pain intensity using a visual analog scale of pain ratings. Secondary endpoints include, among others, time to onset of pain relief, use of analgesic rescue medication and the patient's global evaluation. These primary and secondary efficacy endpoints are widely recognized measures of analgesic efficacy. The clinical trial is one of four pivotal studies required by the FDA to support an NDA filing for an acute pain indication, said the release.
This clinical trial provides another informative model for evaluating the safety and efficacy of bicifadine in the management of acute pain. Other ongoing phase III clinical trials for bicifadine include double-blind placebo controlled evaluations of several bicifadine dosing regimens in patients with pain following bunionectomy surgery and in patients with chronic lower back pain. Also ongoing, is a phase III long-term open label clinical trial study in patients with chronic lower back pain, a trial that utilizes standard of care as a control treatment, the release stated.
Bicifadine is a chemically novel molecule with a unique profile of pharmacological activity. In regard to mechanism of action it is a balanced SNRI (serotonin and norepinephrine reuptake inhibitor) and is not an opiate nor NSAID (nonsteroidal anti-inflammatory drug) nor a COX-2 inhibitor. In animal models, bicifadine does not demonstrate any significant abuse liability, addiction or dependence potential.
Bicifadine has also demonstrated statistically significant analgesic effects in two placebo controlled clinical trials in patients with pain following third molar dental surgery.
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular, that involve alterations in neuronal processing. Its product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain, anxiety, and depression. In addition, its partner Neurocrine has filed two NDAs for the treatment of indiplon in insomnia.
The company has completed enrollment of 50% (300) patients in its pivotal, phase III, U.S. clinical trial with bicifadine in patients with moderate to severe chronic lower back pain and intends to complete the interim futility analysis in the fourth quarter of 2005. Enrollment in the trial is expected to be completed by year end 2005.
It has also announced that DOV and Merck have amended their 2004 license agreement covering the clinical and commercial development activities of DOV 21,947 and DOV 216,303. The amendment will allow certain development contemplated by the license agreement for DOV 21,947 to be undertaken by the Company and permit expansion of the parties' relationship to include an additional triple reuptake inhibitor from the company's preclinical pipeline.
BY OUR PHARMA CORRESPONDENT
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