HOUSTON, July 13 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced the Company sponsored a symposium on therapeutic strategies for treatment-resistant depression (TRD) at the annual Collegium Internationale Neuro-Psychopharmacologicum (CINP) Meeting, July 9-13, 2006 in Chicago, Illinois. The symposium, titled, “The Past, Present and Future Therapies for Treatment-Resistant Depression,” took place on Sunday, July 9, from 3:00 - 5:00 p.m. David L. Dunner, M.D., Director, Center for Anxiety and Depression, Professor Emeritus, Department of Psychiatry and Behavioral Sciences, University of Washington, served as moderator. The speakers reviewed new findings on the clinical use of various stimulation therapies, including VNS Therapy(TM), and provided an update on the current clinical strategies being employed to better understand and treat TRD.
“About four million people in the U.S. experience TRD, a chronic, disabling and life-threatening form of depression,” commented Dr. Dunner. “The need for effective treatment strategies with long-lasting benefits and minimal side effects is crucial if we are to have any hope of treating this severely ill patient population. In recent years, new treatment modalities have emerged, among them, the only FDA-approved treatment option specifically designed for this patient population, VNS Therapy. This symposium provided psychiatrists from all over the world with insight into the various treatment strategies available to treat TRD and also examined mechanism of action of VNS Therapy and its success in treating these patients.”
Symposium presenters included: * David L. Dunner, M.D., Director, Center for Anxiety and Depression, Professor Emeritus, Department of Psychiatry and Behavioral Sciences, University of Washington, discussed the historical and current therapeutic options available for patients with TRD, described the poor long-term outcomes for patients with TRD who are treated with treatment as usual (TAU), and presented long-term data for VNS Therapy in TRD. * Martin B. Keller, M.D., Chair, Department of Psychiatry and Human Behavior, Brown University, reviewed long-term outcomes of the National Institute of Mental Health (NIMH) Collaborative Depression Study and described the objectives and protocol design of the TRD Patient Registry, which is the first research to prospectively and comprehensively assess the long-term course and outcome of patients with TRD. * Charles B. Nemeroff, M.D., Ph.D., Professor and Chairman of the Department of Psychiatry and Behavioral Sciences at Emory University, presented the body of evidence related to mechanism of action for VNS Therapy in TRD. * Harold Sackeim, Ph.D., Professor of Psychiatry and Radiology at Columbia University, addressed future applications of various investigational and approved neuromodulation treatment modalities, including rTMS, DBS, ECT and VNS Therapy.
“We are pleased that the results of VNS Therapy research were presented at this important international meeting,” commented Richard L. Rudolph, M.D., Vice President, Clinical and Medical Affairs and Chief Medical Officer, Cyberonics. “Cyberonics is committed to research and educating psychiatrists in order to provide informed use of VNS Therapy and the best possible treatment for patients who have TRD. We recently announced a landmark patient registry created to provide new insight into TRD and VNS Therapy. We are eagerly looking forward to the results of various ongoing VNS Therapy studies that examine mechanism of action and dosing.”
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 a potential treatment for a variety of other disorders. 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 .
CONTACT INFORMATION: Helen Shik, Vice President Schwartz Communications 230 Third Avenue Waltham, MA 02451 Main: (781) 684-0770 Fax: (781) 684-6500 hshik@schwartz-pr.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.
