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.

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table border=0 width= valign=top cellpadding=2 cellspacing=7trtd valign=top class=jfont style=font-size:85%;font-family:arial,sans-serifbrdiv style=padding-top:0.8em;img alt= height=1 width=1/divdiv class=lha href=http://www.citywebshopper.net/articles/includes/redirect.php?url=http://wcbstv.com/seenat11/economy.depression.financial.2.838009.htmlcid=1256477225ei=z_TwSLfMMKjk6gPXwuC7Bwusg=AFQjCNFYdiFtkUkYtE65HVUWDGz2fmjcSAHealthWatch: bDepression/b And The Economy/abrfont size=-1font color=#6f6f6fWCBS-TV New York,nbsp;NYnbsp;-/font nobr15 hours ago/nobr/fontbrfont size=-1NEW YORK (CBS) ― More than 18 million Americans are affected by bdepression/b yearly, and our economic crisis is only making matters worse. b.../b/font/div/font/td/tr/table
table border=0 width= valign=top cellpadding=2 cellspacing=7trtd valign=top class=jfont style=font-size:85%;font-family:arial,sans-serifbrdiv style=padding-top:0.8em;img alt= height=1 width=1/divdiv class=lha href=http://www.citywebshopper.net/articles/includes/redirect.php?url=http://www.sacbee.com/103/story/1305598.htmlcid=1256526808ei=z_TwSLfMMKjk6gPXwuC7Bwusg=AFQjCNG0KYzde1KGC1k89zdxuy37nZDlCwUC Davis prof analyzes today#39;s crisis vs. Great bDepression/b/abrfont size=-1font color=#6f6f6fSacramento Bee,nbsp; USAnbsp;-/font nobr11 hours ago/nobr/fontbrfont size=-1Rauchway is a professor of history at the University of California, Davis, and the author of the new book quot;The Great bDepression/b and the New Deal: A Very b.../b/fontbrfont size=-1a href=http://www.citywebshopper.net/articles/includes/redirect.php?url=http://venturebeat.com/2008/10/10/remaining-objective-when-fear-is-in-the-air/cid=1256526808ei=z_TwSLfMMKjk6gPXwuC7Bwusg=AFQjCNEX15DLnB4Phn4oMT9SL5PDSDk2TwRemaining Objective When Fear is in the Air/a font size=-1 color=#6f6f6fnobrVentureBeat/nobr/font/fontbrfont class=p size=-1a class=p href=http://news.google.com/news?sourceid=navclientie=ISO-8859-1rls=GGLG,GGLG:2005-22,GGLG:enncl=1256526808hl=ennobrall 4 news articles/nobr/a/font/div/font/td/tr/table
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When Your Fears and Depression Have the Best of You

What do you do when your fears and depression are... Read More

Major Symposium About Vagus Nerve Stimulation & Depression at the American Psychiatric Association

A major symposium about vagus nerve stimulation as a treatment... Read More

How to Uncover the Reason You Cant Sleep Tonight

If you are like me ...you love your sleep!Sleep deprivation... Read More

Being A Victim Is Always A Choice

Do you blame your past, your family, your partner, your... Read More

Wellbutrin For Depression: When Its More Than Just The Blues

We all have blue days:We're missing someone we've lost, the... Read More

10 Simple Coping Strategies When a Family Member Has Clinical Depression

1.Remember that it is an illness:Clinical depression often requires medical... Read More

Fighting Depression by Restoring Your Routines

When we have depression, one of the things we drop... Read More

Control Your Own Level of Motivation

When I first mention this to most people, they really... Read More