HOUSTON, May 25 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that the results of analyses of suicidality and worsening depression during two years of treatment with adjunctive VNS Therapy(TM) from the D-02 pivotal study were presented at the annual American Psychiatric Association (APA) meeting, May 20-25, 2006 in Toronto, Canada. William Burke, M.D., Professor and Vice Chair of the Psychiatry Department, University of Nebraska Medical Center and co-author of the study, presented data from the first 24 months of the pivotal study of VNS Therapy for treatment-resistant depression (TRD). The study followed 235 patients of whom 205 received VNS Therapy over a two-year period and evaluated suicides, attempted suicides, suicidal ideation and hospitalizations for worsening depression. The authors conclude that suicidality and hospitalizations due to worsening depression generally declined during 24 months of VNS Therapy, particularly in those patients who responded to the treatment.
“Treatment-resistant depression is a public health crisis,” commented Dr. Burke. “Patients with treatment-resistant depression are at a significant risk for suicide and worsening depression. Treatment-as-usual has failed this patient population and VNS Therapy is a much-needed and welcome new treatment option. It is especially significant and encouraging to find that over time, patients treated with VNS Therapy report less suicidal ideations and tendencies and fewer hospitalizations due to worsening depression. In fact, these study results indicate a positive correlation between the length of time a patient is treated with VNS Therapy and a decline in the number of suicide attempts or ideations.”
“This study further underscores qualified psychiatrists’ and fully- informed TRD patients’ needs for parity with neurologists and refractory epilepsy patients in access to VNS Therapy,” said Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer. “This data shows declines in suicidality and hospitalizations due to worsening depression and adds to a rapidly growing body of valid, peer-reviewed scientific evidence on long-term patient outcomes. It also confirms the unique safety, effectiveness and cost effectiveness of VNS Therapy, the only FDA-approved long-term treatment specifically for patients with chronic or recurrent treatment-resistant depression.”
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. It is estimated that more than four million Americans experience TRD and one-third of these patients experience significant suicidal ideas or gestures.
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.
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.
ABOUT VNS THERAPY AND CYBERONICS
Information on Cyberonics, Inc. and VNS Therapy is available at http://www.cyberonics.com and http://www.vnstherapy.com .
Cyberonics, Inc.
CONTACT: Helen Shik, Vice President of Schwartz Communications,+1-781-684-0770, or fax, +1-781-684-6500, or hshik@schwartz-pr.com , forCyberonics, Inc.
