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FDA Deems Vagus Nerve Therapy Approvable as a Treatment for Depression
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.
Other Articles in This Category: Vagus Nerve Stimulation: What are the Benefits and How Does It Relieve Depression?25% of Americans Suffer From a Mental Illness and do Not Get Adequate Relief From Antidepressants New Treatment for Depression to be FDA Approved by Late June Depression is a Choice Senate Finance Committee Delays FDA Approval of Vagus Nerve Stimulation Therapy for Depression When Your Fears and Depression Have the Best of You Antidepressants 101- What You Absolutely Need to Know Being A Victim Is Always A Choice |
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