HOUSTON, May 22 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that data demonstrating the long-term durability of antidepressant response to VNS (Vagus Nerve Stimulation) Therapy(TM) in patients with treatment-resistant depression (TRD) were presented at the annual American Psychiatric Association (APA) Meeting in Toronto, Canada. Patients included in this study had experienced depression characterized by exceptional levels of chronicity and treatment-resistance. Yet, the majority of patients that experienced substantial clinical benefit either early or later after beginning VNS Therapy maintained the improvement for up to 24 months.
In the studies analyzed, between 61% and 79% of patients with TRD who responded to VNS Therapy maintained response at 24 months. The durability of benefit was not attributable to alterations in other treatments. Harold A. Sackeim, Ph.D., Professor of Psychiatry and Radiology at Columbia University and Chief Emeritus of Biological Psychiatry at the New York State Psychiatric Institute and Stephen K. Brannan, M.D., Medical Director, Cyberonics, were lead authors of the poster presentation.
Relapse of depressive episodes is frequent in patients with major depression. It is estimated that more than 40 percent of patients experience a recurrence after two years and more than 60 percent experience recurrence after five years.(1) Eighty to 90 percent of those patients having experienced two or more episodes of depression will have additional episodes.(2) Electroconvulsive therapy (ECT) is considered by many psychiatrists as the most effective acute intervention for TRD. However, the majority of TRD patients relapse during the first year following response to ECT.(3)
"These data showing durability of response with VNS Therapy are rather remarkable under any circumstance, but particularly for the patient population studied here," said Dr. Sackeim. "These findings regarding long-term sustained effectiveness are very encouraging for psychiatrists, patients with treatment-resistant depression, and for payers, all of whom are looking for more effective and cost-effective treatment options for chronic or recurrent depressions that have failed to respond or sustain a response to multiple treatments."
"This research highlights a unique and one of the most valuable attributes of VNS Therapy," added Dr. Brannan. "Many patients that did not achieve a response or sustain a response during some 20 years of treatment with over 15 different antidepressants not only responded to VNS Therapy, but sustained that response out to two years. These findings, combined with the decreases in suicidality and hospitalizations due to worsening depression also reported here at APA, confirm the positive effect that VNS Therapy has on long-term TRD patient outcomes and healthcare utilization."
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 treatment-resistant depression (TRD). Recent 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.
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.
VNS Therapy is also FDA-approved as an adjunctive therapy used to reduce the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of research as potential treatments for anxiety disorders, Alzheimer's disease, bulimia, chronic headache/migraine and morbid obesity. In total, more than 40,000 patients have accumulated over 100,000 patient years of experience with VNS Therapy confirming that VNS Therapy is safe, effective and cost effective.
ABOUT VNS THERAPY AND CYBERONICS
Information on Cyberonics, Inc. and VNS Therapy is available at http://www.cyberonics.com/ and http://www.vnstherapy.com/ .
(1) Keller MB, Boland R. "Implications of Failing to Achieve Successful
Long-Term Maintenance Treatment of Recurrent Unipolar Major
Depression." Biol Psychiatry; 1998. 44(5):351.
(2) Crown W. "The Impact of Treatment-Resistant Depression on Health
Care Utilization and Costs," J. Clin Psychiatry; 2002. 63:11.
(3) Sackeim HA, Haskett RF, et. al "Continuation pharmacotherapy in the
prevention of relapse following electroconvulsive therapy: a
randomized controlled trial. JAMA. 2001;285:1299-1307
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