Title: Results From Cyberonics' Depression Pilot Study
Birdbomb - September 13, 2005 02:31 PM (GMT)
LINK TO ARTICLEJournal of Clinical Psychiatry Publishes Two-Year Results From Cyberonics' Depression Pilot Study
Tuesday September 13, 9:00 am ET
42% Response and 22% Remission Rates Seen After Two Years of Adjunctive VNS
HOUSTON, Sept. 13 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that the peer-reviewed two-year results from its treatment-resistant depression D-01 pilot study were published in the September 2005 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry 66:9, September 2005). The article, entitled "Two-Year Outcome of Vagus Nerve Stimulation (VNS) for Treatment of Major Depressive Episodes," by Ziad Nahas, M.D., Associate Professor at Medical University of South Carolina (MUSC); Medical Director of Brain Stimulation Lab at MUSC; and Director of Mood Disorder Program at MUSC, et al, presents the three-month, one-year and two- year response and remission rates from the 60-patient VNS pilot study conducted at Medical University of South Carolina, Baylor College of Medicine, University of Texas Southwestern Medical Center and Columbia University. Based on last observation carried forward analyses, HAM-D response rates were 42% and HAM-D remission rates were 22% after two years of adjunctive VNS Therapy™ in patients that had received a mean of 15.7 unsuccessful clinical treatments in the current depressive episode, the median of which was 6.8 years. At two years, 81% of the study participants were still receiving VNS Therapy.
"The two-year results from the D-01 pilot study for VNS Therapy found short-term and long-term benefits for more than one-third of treatment- resistant depression patients in the trial. Benefits seen at one year were largely sustained for the group at two years, and one of two initial responders continued to evidence response after two years," commented senior author Mark George, M.D., Distinguished Professor of Psychiatry, Radiology and Neurosciences at the Medical University of South Carolina, who oversaw the first VNS implant for depression at MUSC in 1998. "These long-term data on these initial patients are part of a growing body of peer-reviewed literature further confirming the significant relationship between VNS Therapy and long- term improvements in overall presence of depression and its symptoms. VNS Therapy's availability for treatment-resistant depression patients provides a new option to try when first-line treatments are unable to provide relief from chronic depression."
"Publication of the scientific evidence that was the foundation for FDA approval in respected peer-reviewed journals such as Journal of Clinical Psychiatry facilitates well-informed decisions by psychiatrists and payers and accomplishment of Cyberonics' mission to improve the lives of people touched by treatment-resistant depression," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "This publication follows the recent publication of important long-term data from the D-02 pivotal study showing sustained and/or improving response and remission rates in three peer-reviewed articles in Biological Psychiatry. We expect that the body of compelling, peer-reviewed evidence supporting the use and third-party payer coverage of VNS Therapy in treatment-resistant depression will grow rapidly in the coming months.
"The momentum in peer-reviewed publications is consistent with the overall momentum that has been built in the physician, payer and patient communities in first month of the TRD launch," continued Mr. Cummins. "Almost 3,000 TRD patients have requested information from Cyberonics and over 1,000 of those are actively moving through our education and insurance verification and prior authorization processes. Interestingly, the number of TRD patients identified by their psychiatrists as VNS candidates quarter to date is essentially the same as the number of epilepsy candidates identified by neurologists. We are also making good progress with physician education. We plan to educate over 5,000 psychiatrists and VNS surgeons in fiscal 2006 and so far our regional education and training programs have been largely oversubscribed. In terms of TRD coverage, coding and reimbursement, with AMA's approval of the VNS programming codes for use in TRD, the remaining challenge is obtaining case- by-case and regional and national coverage. While there is much work to be done, we are pleased with our progress towards national coverage policies and with the favorable case-by-case coverage decisions obtained from a variety of payers by our Case Management team. Although VNS Therapy clearly has momentum in TRD, we expect that at least three quarters will be required for us to have a clear understanding of TRD patient conversion rates and cycle times from identification to implant."
The publication of peer-reviewed data follows FDA approval of 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 implantable device-based treatment for depression and the first treatment specifically developed, studied, approved and labeled for treatment-resistant depression. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of investigational clinical studies as a potential treatment for anxiety disorders, Alzheimer's disease, bulimia and chronic headache/migraine