VNS therapy (Vagus Nerve Stimulation Therapy System) has for a while been an FDA-approved adjunctive treatment for medically refractory partial onset seizures. Now, it seems, that FDA is considering an approval of VNS therapy for treatment-resistant depression.

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HOUSTON, Feb. 2 — Cyberonics, Inc. today announced that the United States Food and Drug Administration (FDA) has deemed the Vagus Nerve Stimulation Therapy System (VNS Therapy) approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cyberonics, FDA indicated that final approval was conditional on final labeling, final protocols for a post- approval dosing optimization study and patient registry, satisfactory compliance with Quality System Regulations (QSR) and satisfactory resolution of any outstanding bioresearch monitoring issues.

“FDA’s approvable decision is a major step towards the transformation of VNS Therapy, Cyberonics and the neuromodulation industry,” continued Mr. Cummins. “Cyberonics’ mission is to improve the lives of people touched by medically refractory epilepsy, treatment-resistant depression and other inadequately treated chronic disorders that prove to be treatable with our patented therapy, VNS. Today, the urgent unmet medical need in treatment- resistant depression is more than ten times the unmet medical need in epilepsy. There are an estimated four million Americans who suffer from treatment-resistant depression versus some 400,000 who have medically refractory epilepsy. In epilepsy, VNS is one of many FDA-approved adjunctive treatments for medically refractory partial onset seizures, whereas in depression, if final approval occurs, VNS will be the only FDA-approved treatment specifically for chronic or recurrent treatment-resistant depression.

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