Cyberonics Inc.: VNS Therapy(R) Effective at Reducing Depressive Symptoms in Patient Population Experiencing Chronic and Recurrent Treatment-Resistant Depression

HOUSTON, May 27 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced the results of a multicenter, double-blind, randomized dosing study (D-21) conducted as a condition of the Food and Drug Administration (FDA) approval for VNS Therapy for patients with chronic and recurrent treatment-resistant depression in July 2005. This dosing study showed a consistent, sustained and clinically meaningful decrease in depression symptoms across all treatment groups as measured by multiple validated depression assessment scales. Four physician-rated depression scales and one patient-rated depression scale used in this study showed that adjunctive VNS Therapy provided efficacy that improved over time at all dosing levels. After long-term (50 weeks) treatment with VNS Therapy, overall depression symptom improvement ranged from 32.4% to 42.0%; response rates ranged from 26.7% to 53.3%; and remission rates ranged from 14.6% to 22.5% as measured by the five depression assessment scales.

D-21 compared the safety and effectiveness of adjunctive VNS Therapy administered at different stimulation levels to 331 adult patients enrolled at 29 U.S. study centers. Patients were randomized to receive one of three stimulation levels (low, medium or high) during the acute phase (22 weeks). The study design allowed patients in the low and medium stimulation groups to receive increased levels of stimulation after 22 weeks. Patients were followed in the study for a total of 54 weeks.

Patients participating in this dosing study were experiencing very severe levels of chronic and recurrent treatment-resistant depression that had been unresponsive to multiple antidepressant treatments. Key characteristics and demographics of study participants include:

After 50 weeks of treatment, patients randomized to the medium stimulation group achieved an average of 42.0% improvement in depression symptoms from baseline as measured by the Montgomery-Asberg Depression Rating Scale (MADRS), one of the most commonly-used and extensively-validated rating scales to assess the range and change of depression symptoms in response to antidepressant treatments. Response, defined as greater than or equal to 50% reduction in depression symptoms, was achieved by 47.8% of patients, and remission, considered to be the absence of depression symptoms, was achieved by 21.1% of patients as measured by the same scale. Also, 80.6% of patients achieving response at 22 weeks maintained response at 50 weeks, indicating a high level of sustained response.

Patients receiving high stimulation did not show significantly greater improvement than those receiving medium or low stimulation at the end of the 22-week acute phase (the primary outcome measure). However, there was a statistically significant decrease in depression symptoms across all five depression scales over time, a secondary efficacy endpoint.

The overall trend and magnitude of depression symptom decrease is consistent with prior long-term VNS Therapy studies in similar patient populations experiencing chronic and recurrent treatment-resistant depression. Likewise, treatment-emergent side effects were similar to those previously reported for VNS Therapy in other studies.

“Chronic and recurrent treatment-resistant depression is a very debilitating illnessmany of these people suffer for years without any improvement despite numerous treatment trials. Additionally, these patients are rarely included in clinical studies and very few effective treatment options exist for them,” stated Charles R. Conway, M.D., Associate Professor of Psychiatry at Washington University School of Medicine and research faculty at St. Louis University School of Medicine. “In my 10 years of research and clinical use of VNS Therapy, I have seen unparalleled efficacy in a patient population for whom multiple standard-of-care treatments have failed. The long-term sustained efficacy seen with this treatment is particularly compelling and unique.”

“The results of this post-market dosing study add to the growing body of evidence for adjunctive VNS Therapy in a severely ill patient population where multiple prior treatments have failed,” said Dan Moore, President and CEO. “Efficacy that improves over time and lasts long-term in this patient population has been demonstrated in multiple studies involving approximately 1,000 patients. With these results in hand, we are continuing to evaluate our alternatives for addressing payer coverage and reimbursement and developing a business around the depression indication, while maintaining focus on our core epilepsy business.”

About Cyberonics, Inc. and VNS Therapy®

Cyberonics, Inc. (Nasdaq: CYBX) is a medical technology company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in approximately 60 countries worldwide, and to date more than 55,000 patients have been implanted with the device.

Additional information on Cyberonics and VNS Therapy is available at www.cyberonics.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,” “forecast,” or other similar words. Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information if those facts change or if 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 payer coverage and reimbursement for and developing a business around the depression indication for VNS Therapy. 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 other indications; satisfactory completion of post-market studies required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; 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 indications; 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; the results of the previously disclosed governmental inquiries; the potential identification of material weaknesses in our internal controls over financial reporting; risks and costs associated with such governmental inquiries and any litigation relating thereto, and practices and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC). For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 24, 2009, and Quarterly Reports on Form 10-Q for the fiscal quarters ended July 23, 2009, October 23, 2009, and January 22, 2010.

SOURCE Cyberonics, Inc.