July 7, 2006 – 1:52 AM
HOUSTON, July 5 /PRNewswire-FirstCall/ — Cyberonics, Inc. (NASDAQ:CYBX) today announced publication in the July 2006 issue of Neuropsychopharmacology (Neuropsychopharmacology 2006;31:1345-1355) of a peer-reviewed review article summarizing the results of a large body of studies that have investigated the mechanism of action of Vagus Nerve Stimulation (VNS) Therapy. The review also summarizes the principal safety and efficacy data for VNS Therapy as a treatment for treatment-resistant depression (TRD) and pharmacoresistant epilepsy. The authors provide a basis for how VNS Therapy is unique in its antidepressant activity and conclude that VNS Therapy is a well-tolerated and important treatment option for a subset of patients with TRD. Charles B. Nemeroff, M.D., Ph.D., Emory University is lead author of the article, "VNS Therapy in Treatment-Resistant Depression: Clinical Evidence and Putative Neurobiological Mechanisms."
The authors discuss findings of recent imaging studies conducted after acute and during long-term treatment of VNS Therapy for patients with TRD. These imaging studies revealed changes in medial temporal structures of the brain. Studies to identify the effects of VNS Therapy on neurotransmitter systems showed that VNS Therapy alters the firing rates of serotonergic neurons, those neurons implicated in the mechanism of action of the serotonin reuptake inhibitor antidepressant drugs, by a mechanism that is distinct from antidepressant drugs and consistent with the progressive increase in antidepressant response observed in clinical studies of VNS Therapy. In addition, data on mapping neural substrates support the concept that VNS Therapy acts directly by stimulating brain stem structures and indirectly by regulating the activity of neurons in limbic and cortical regions involved in mood regulation.
"After reviewing all the available data, taken together, it is clear that VNS Therapy is a promising treatment for patients living with TRD. Given the nature of TRD, it is exceptional that the antidepressant effect of VNS Therapy has been shown to improve over time and is sustained long-term for patients with TRD," commented Dr. Nemeroff. Results of ongoing clinical and imaging studies will be critical to increasing our understanding of the mechanisms of action that mediate the beneficial effects of VNS Therapy for TRD."
"This peer-reviewed evaluation of existing research on VNS Therapy demonstrates the importance of this treatment option for patients with TRD. I commend the authors for reviewing the data on mechanism of action and discussing the inherent value in VNS Therapy as a safe and effective treatment option for patients with TRD," said Robert P. ("Skip") Cummins, Cyberonics Chairman of the Board and CEO.
"Cyberonics recently announced the initiation of three mechanism of action studies at leading institutions across the country as well as a multicenter dosing study to investigate treatment outcomes for patients with TRD. Further, data was recently presented at the American Psychiatric Association Annual Meeting on the unprecedented durability of response in patients with TRD after two years of treatment with VNS Therapy."
In July 2005, the FDA approved VNS Therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. VNS Therapy is the first FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with TRD. Peer-reviewed data published in Biological Psychiatry and the Journal of Clinical Psychiatry confirm the association of VNS Therapy with significant antidepressant benefits that are sustained and/or increase over time for patients with chronic or recurrent treatment-resistant depression. Further, recent peer-reviewed data published in the Journal of Clinical Psychiatry shows long-term treatment-as-usual, not including VNS Therapy, is ineffective for patients with treatment-resistant depression.
To date, more than 5,000 psychiatrists have been trained at Cyberonics- sponsored medical education programs, 2,650 psychiatrists have identified over 10,000 potential VNS patients, 180 different payers have approved individual case by case use of VNS Therapy, 1,100 patients have been treated with VNS Therapy and approximately 4,700 patients have been denied access to VNS Therapy by their insurance providers. The Company is actively working with psychiatrists, patients, patient advocacy organizations, employers and payers to provide psychiatrists and patients with TRD the same universal access to VNS Therapy enjoyed by neurologists and their epilepsy patients through broad based coverage policies for the past six years.
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