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Peer-Reviewed Data Demonstrating Long-Term Safety and Efficacy of Cyberonics' VNS Therapy(TM) for Treatment-Resistant Depression (TRD) Published in Leading Psychiatric Journal

Posted on: Wednesday, 31 August 2005, 15:00 CDT

HOUSTON, Aug. 31 /PRNewswire-FirstCall/ -- Cyberonics, Inc. today announced that peer-reviewed data from the D-02 pivotal study including the randomized, controlled acute phase trial, one-year open study and one-year comparison of the D-02 patients treated with VNS plus treatments-as-usual and the D-04 patients treated only with treatments-as-usual (no VNS) have been published in the September 1 issue of Biological Psychiatry. These articles, published in the official journal of the Society for Biological Psychiatry, confirm the association of VNS Therapy with significant antidepressant benefits that are sustained and/or growing over one year for patients with chronic or recurrent treatment-resistant depression.

The first article, "Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial" (A. John Rush, MD, Professor and Vice Chairman for Research, Department of Psychiatry, Betty Jo Hay Chair in Mental Health, Rosewood Corporation Chair in Biomedical Science, University of Texas Southwestern Medical Center, Dallas, TX, et al.), reports outcomes from a ten-week, randomized-control, acute phase study with 235 patients in 21 sites. The patients in the D-02 trial suffered from some of the most chronic and resistant depressions ever studied. Although the primary outcome measure did not reach statistical significance, VNS Therapy was associated with greater symptom reduction by all primary and secondary measures and did reach statistical significance in an important secondary measure. Additionally, VNS Therapy was safe and well-tolerated in this patient population.

The second article reports the 12-month outcomes in the naturalistic long-term phase of the study, "Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study" (A. John Rush, MD, et al.). In this study (n=205), treatment with increased doses of adjunctive VNS Therapy over a one-year period of time resulted in statistically significant and clinically meaningful reductions in depressive symptoms across all primary and secondary measures. Twenty-seven percent of patients with chronic or recurrent TRD experienced response, and 16% of patients experienced remission. These patients had experienced major depressive disorder for an average of 25 years and had failed to respond or sustain a response to an average of almost 20 different antidepressant treatments, including all available antidepressant medications, psychotherapy, and in some cases, ECT (electroconvulsive therapy). Importantly, 73% of patients experiencing response at three months, maintained response after one year of treatment with adjunctive VNS Therapy.

The third article, "One-Year Comparison of Vagus Nerve Stimulation with Treatment as Usual for Treatment-Resistant Depression" (Mark S. George, MD, Distinguished Professor of Psychiatry, Radiology and Neurosciences, Director, MUSC Center for Advanced Imaging Research, Director, Brain Stimulation Laboratory, Medical University of South Carolina, Charleston, SC, et al.), evaluated two similar groups of patients with treatment-resistant depression, the D-02 group (n=205) who received adjunctive VNS Therapy with treatment as usual (TAU) and the D-04 study group receiving TAU alone (n=124). These two groups were comparable in terms of baseline characteristics. The differences in therapeutic effects between the two patient populations were both statistically significant and clinically important for the patients receiving adjunctive VNS Therapy as compared to TAU alone. Twenty-seven percent of patients receiving adjunctive VNS Therapy experienced response compared to 13% of patients receiving TAU. More than twice as many patients receiving adjunctive VNS Therapy experienced remission. Response was maintained long-term for 73% of the VNS treated patients. In contrast, only one of the seven acute responders receiving TAU maintained response at 12 months.

"The response and remission and sustained long-term benefits realized by the patients treated with adjunctive VNS Therapy is remarkable, given that participants in the trials were some of the most treatment-resistant, depressed patients ever studied, with at least half having been hospitalized for the disease at least once," commented Dr. A. John Rush, MD, Professor and Vice Chairman for Research, Department of Psychiatry, Betty Jo Hay Chair in Mental Health, Rosewood Corporation Chair in Biomedical Science, University of Texas Southwestern Medical Center, Dallas, TX. "The VNS studies presented in these publications provide substantial evidence of a growing benefit of VNS Therapy over time when other treatments have not worked or have stopped working. This is particularly encouraging given the nature of treatment-resistant depression, a devastating and difficult to treat condition. Although VNS does not work for everyone, it does offer psychiatrists and patients the first FDA-approved, safe and effective long-term treatment option specifically for patients with chronic or recurrent treatment-resistant depression."

"Publication of the scientific evidence that was the foundation for FDA approval in respected peer-reviewed journals such as Biological 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," added Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer.

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.

ABOUT VNS THERAPY AND CYBERONICS

Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. The Company's initial market was epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the second most prevalent neurological disorder. The Cyberonics VNS Therapy System was approved by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The VNS Therapy System is also approved for sale as a treatment for epilepsy in all the European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 100,000 patient years of experience using VNS Therapy.

The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." As part of FDA's approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000-patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician's and Patient's Manuals and other information at http://www.cyberonics.com/ or http://www.vnstherapy.com/ or call 1-877-NOW 4 VNS.

The VNS Therapy System has been approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression) since 2001.

Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com/ .

Cyberonics, Inc.

CONTACT: Pamela B. Westbrook, Vice President of Finance and CFO ofCyberonics, Inc., +1-281-228-7200, or fax, +1-281-218-9332, orpbw@cyberonics.com ; or Risa Goldman, Director of Schwartz Communications,+1-781-684-0770, ext. 6570, or fax, +1-781-684-6500, orrisag@schwartz-pr.com , for Cyberonics, Inc.

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

Source: PRNewswire-FirstCall

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