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Study Published in Journal of Clinical Psychiatry Shows Long-Term Treatment- As-Usual Is Ineffective for Patients With Treatment-Resistant Depression

Posted on: Thursday, 8 June 2006, 09:01 CDT

HOUSTON, June 8 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that results of its D04, two-year, prospective, multi-center, observational study of patients with chronic or recurrent treatment-resistant depression (TRD) treated with unlimited treatment-as-usual (TAU) have been published in the May 2006 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry 67:5, May 2006). The D04 study provided a non-randomized control group for the long-term D02 pivotal study of TRD patients treated with adjunctive VNS Therapy. The published D04 results show that despite the wide range of treatment options available for depression, most patients with a substantial degree of treatment-resistant depression who were treated with TAU continued to have significant depressive symptoms and functional disability during two years of active treatment. David L. Dunner, M.D., Professor and Director of the Center for Anxiety and Depression at the University of Washington, is lead author of this article.

The article entitled "Prospective, Long-Term, Multicenter Study of the Naturalistic Outcomes of Patients With Treatment-Resistant Depression," reports outcomes for 124 patients, at 13 study sites, with severe TRD treated with medications, electro-convulsive therapy (ECT) and/or psychotherapy over a period of two years. Sixty-four percent of the patients never responded to TAU at any observation point during the study. More than eighty percent never achieved remission at any observation point during the study. However, patients who responded to TAU at some point during the study generally had only intermittent and transient response patterns, indicating a high likelihood of relapse in this patient population treated with TAU. Of the 13 patients reaching response at 12 months, only 5 maintained response at 24 months, and only 1 of the 4 patients reaching remission at 12 months maintained remission at 24 months.

"Because this unprecedented study included a patient population typically excluded from clinical research, we now have a much clearer understanding of treatment-resistant depression. This study confirms that traditional forms of treatment, even after two years and despite augmentation and combination strategies, are inadequate in alleviating depressive symptoms in patients with chronic, treatment-resistant depression," commented Dr. Dunner. "The recent FDA approval of VNS Therapy(TM) as the only treatment specifically studied and indicated for this patient population is an important step forward in providing new and more effective treatment options for this patient population. Qualified psychiatrists and patients with TRD need unfettered access to VNS Therapy, whose long-term safety and effectiveness, unlike that of TAU, is proven in this patient population."

To be included in the study, patients had to have chronic or recurrent depression and had to be experiencing a current major depressive episode. Additionally, the patients had to have failed to respond to at least two adequately delivered antidepressant treatments in the current episode. The study inclusion criteria were similar to those used for the D02 VNS Therapy pivotal study. Patients had experienced depression for an average of 26 years, and the average duration of the current episode was almost 6 years. Patients had also experienced an average of 4 failed antidepressant treatments of adequate dose and duration in their current episode.

"This landmark research shows that unlimited traditional antidepressants satisfy neither TRD patients' nor their payers' needs for FDA-approved treatments that provide long-term durability of response," said Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "The disappointing response, remission and sustained response rates observed in this study reflect the extraordinary chronicity and resistance of the patients' depressions and the fact that none of the traditional antidepressants covered by payers and used to treat Americans with TRD has ever been systematically studied or proven safe and effective for use in severe TRD. The poor outcomes produced by traditional antidepressants in TRD patients result in frequent hospitalizations and rapid escalation of annual healthcare costs. Recent studies of private payer and Medicare claims databases show that previously-hospitalized TRD patients cost payers between $31,000 and $45,000 per patient per year, the majority of which is in depression-related hospitalizations. Total annual healthcare costs and annual depression-related hospitalization costs for previously hospitalized TRD patients are 6.5 times and 3.4 times, respectively, the total annual healthcare costs of patients with non-resistant depressions.

"As the long-term control for the pivotal VNS trial, these D04 results also provide a frame of reference for the unique value of VNS Therapy to TRD patients and their payers," continued Mr. Cummins. "VNS Therapy is the only treatment ever studied, proven safe and effective, FDA-approved and fully- informatively labeled for the long-term treatment of chronic or recurrent TRD. Contrary to these D04 and other studies' results demonstrating the ineffectiveness of TAU in TRD, data from the VNS studies presented at the recent American Psychiatric Association Annual Meeting showed remarkable two- year durability of antidepressant response and that suicidality and hospitalizations due to worsening depression generally decreased during two- years of VNS Therapy."

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.

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/ .

SAFE HARBOR STATEMENT

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including "may,""believe,""will,""expect,""anticipate,""estimate,""plan,""intend," and "forecast," or other similar words. Statements contained in this press release are based upon information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information should those facts change or should we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning (i) results of the economic study demonstrating how VNS Therapy can affect costs associated with TRD and (ii) the attainment of regional and national insurance coverage policies for TRD. Our actual results may differ materially. Important factors that may cause actual results to differ include, but are not limited to: continued market acceptance of VNS Therapy and sales of our product; the development and satisfactory completion of clinical trials and/or market test and/or regulatory approval of VNS Therapy for the treatment of Alzheimer's disease, anxiety, or other indications; adverse changes in coverage or reimbursement amounts by third-parties; intellectual property protection and potential infringement claims; maintaining compliance with government regulations and obtaining necessary government approvals for new applications; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to Cyberonics' most recent filings with the SEC, including its Form 10-K for the fiscal year ended April 29, 2005.

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.

Web site: http://www.cyberonics.com/http://www.vnstherapy.com/

Source: PRNewswire-FirstCall

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