HOUSTON, May 22 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced the Company sponsored a symposium on treatment-resistant depression (TRD) and VNS Therapy(TM) at the annual American Psychiatric Association (APA) Meeting, May 20-25, 2006 in Toronto, Canada. Cyberonics sponsored the symposium titled, “Treatment-Resistant Depression: New Data, New Approaches,” which took place on Saturday, May 20 from 6:00 - 9:00 p.m. David L. Dunner, M.D., Director, Center for Anxiety and Depression, Professor, Department of Psychiatry and Behavioral Sciences, University of Washington, served as the moderator. The symposium speakers presented new findings on patients with TRD, discussed the definition and characteristics of TRD as well as the most effective treatment strategies.
“Treatment-resistant depression is the most chronic, disabling, life- threatening and expensive form of depression. With few proven treatment options and no well-defined treatment algorithms, it is important that the psychiatric and research communities improve their understanding of TRD and the available treatments for this incredibly difficult-to-treat patient population,” commented Dr. Dunner. “Our overriding goal for this symposium is to improve psychiatrists’ understanding of existing and potential future treatment options for treatment-resistant depression, including VNS Therapy, to improve long-term patient outcomes.”
Symposium presenters included: * David L. Dunner, M.D. presented data from a two-year prospective study of patients with TRD showing that response, sustained response and remission rates are low despite aggressive use of traditional treatments. * Jose V. Pardo, M.D. discussed the effects of VNS Therapy on brain metabolism for treatment-resistant depression. * Francisco A. Moreno, M.D. presented data on association studies that compare patients with treatment-resistant depression, patients who experience sustained remission and healthy patients free of depressive symptoms. He also discussed genetic data on prediction of anti- depressant response. * Alicia R. Rualaz, M.D. reviewed existing data supporting the use of augmentation strategies for treatment-resistant depression and presented data from the only large continuation trial suggesting the potential need to redefine a long-term treatment algorithm for difficult-to-treat depression. * Linda L. Carpenter, M.D. discussed brain stimulation techniques and reviewed efficacy data for investigational and FDA-approved treatment options for treatment-resistant depression including electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), magnetic seizure therapy (MST) and vagus nerve stimulation (VNS) therapy.
During the APA conference, psychiatric experts on VNS Therapy will also be on-hand at the Cyberonics Booth #1576 to discuss experiences with VNS Therapy and to answer questions on mechanism of action, safety, efficacy and tolerability, durability of response and high continuation and adherence rates.
“We are very pleased by psychiatrists’ response so far to our Biological Psychiatry and APA annual meetings initiatives,” commented Michael A. Cheney, Cyberonics’ Vice President of Marketing. “The room for Cyberonics’ industry sponsored symposium was set for 750 people and it appears as though over 850 APA attendees actually attended. The feedback from psychiatrists was that our symposium was one of the most informative and the best-attended of all the Saturday symposia. Many psychiatrists have also come to our booth to “meet the expert” and learn more about TRD, VNS Therapy and the unique VNS Therapy mechanism of action from psychiatric thought leaders. Consistent with our sales messaging research results and our accelerating annual U.S. sales growth, the response so far at APA suggests that awareness, acceptance and demand for VNS among U.S. and international psychiatrists continues to grow. We are now looking forward to the presentation of several important new findings during the upcoming poster presentations.”
VNS Therapy will also be featured at multiple poster presentations at the APA conference. Posters will be presented in the Toronto Convention Centre North, Level 300, Exhibit Hall B:
* “Durability of Antidepressant Response to Vagus Nerve Stimulation,” Monday, May 22 from 3:00 p.m.- 5:00 p.m. * “Prospective, Long-Term, Multicenter Study of the Naturalistic Outcomes of Patients With Treatment-Resistant Depression,” Monday, May 22 from 3:00 p.m. - 5:00 p.m. * “Suicidality in Treatment-Resistant Depression: Results From a 24-Month Trial of Vagus Nerve Stimulation,” Wednesday, May 24 from 3:00 p.m.- 5:00 p.m. * “Cerebral Blood Flow Changes During Vagus Nerve Stimulation for Depression,” Thursday, May 25 from 12:00 p.m. - 2:00 p.m. * “Subacute and Chronic Brain Metabolic Change With Vagus Nerve Stimulation in Depression,” Thursday, May 25 from 12:00 p.m. - 2:00 p.m.
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.
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.
