On February 3, 2005 the U.S. Food and Drug Administration (FDA) notified the manufacturer of the vagus nerve stimulator (Cyberonics, Inc.) that it had deemed its VNS Therapy System 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.
This is an extraordinary announcement and major step for the four million Americans suffering from chronic or treatment-resistant depression towards providing an FDA-approved, informatively labeled, long-term treatment option specifically for their lifelong and life-threatening illness.
The FDA is reviewing the final labeling, which includes the Physician's and Patient's Manuals, and expects to complete that review in a timely manner. When all of the FDA's conditions have been satisfied, the Company plans a formal launch in conjunction with the American Psychiatric Association Annual Meeting in May.
You need to be your own best advocate and educate yourself about how this remarkable FDA approved therapy can change your life. Learn more at www.VagusNerveStimulator.com
The author was a study study subject 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.
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
article_text... Read More
A major survey on depression symptoms from the National Mental Health Association (NMHA), released in july 2001, revealed a dramatic degree of progress in public understanding... Read More
INTRODUCTION Everybody has a story... Read More
No doubt you have seen the recent news headlines about a federal panel that recommended to the FDA that anti-depressant medications carry the strongest possible warning label for use in children and teenagers... Read More
Chronic Fatigue Syndrome is a very misunderstood illness and this is perhaps why there are so many myths about it... Read More
Vagus Nerve Stimulation for Chronic Treatment-Resistant Depression About Vagus Nerve Stimulation VNS is not brain surgery, although it is a treatment that affects the function of the brain... Read More
"Thanks for Noticin' Me" says Eeyore... Read More
While war and poor economic conditions begin to affect people all over the world, more and more people suffer with depression... Read More