On February 3, 2005 the U.S. Meals and Drug Administration (FDA) notified the manufacturer of the vagus nerve stimulator (Cyberonics, Inc.) that it had deemed its VNS Therapy Program approvable as a long-term adjunctive therapy for patients more than the age of 18 with chronic or recurrent therapy-resistant depression in a main depressive episode that has not responded to at least four sufficient antidepressant treatments. In the approvable letter obtained these days by Cyberonics, FDA indicated that last approval was conditional on last labeling, last protocols for a publish-approval dosing optimization research and individual registry.

This is an extraordinary announcement and main stage for the four million Americans suffering from chronic or therapy-resistant depression towards supplying an FDA-approved, informatively labeled, long-term therapy option particularly for their lifelong and existence-threatening illness.

The FDA is reviewing the last labeling, which consists of the Physician’s and Patient’s Manuals, and expects to complete that evaluation in a timely method. When all of the FDA’s circumstances have been happy, the Company plans a formal launch in conjunction with the American Psychiatric Association Yearly Meeting in May.

You need to be your own greatest advocate and teach yourself about how this exceptional FDA approved therapy can alter your existence. Learn much more at www.VagusNerveStimulator.com

The author was a research research topic in the FDA investigational trial of vagus nerve stimulation and chronic depression. He is the author of Out of the Black Hole: The Patient’s Guide to Vagus Nerve Stimulation and Depression and editor of the VagusNerveStimulator.com Web site.