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.
Only somebody who has lived with anxiety ? as either... Read More
On June 15th, 2004, FDA's Medical Devices Panel recommended that... Read More
According to the World Health Organization, 4 of the 10... Read More
When most people hear the words American Indian, visions of... Read More
In every moment of our life we have the choice... Read More
Our innate desire is to be happy, and when we... Read More
Approximately 19 million American adult workers allow depression to limit... Read More
Depression is something that will occur in many people's lives,... Read More
If you are like me ...you love your sleep!Sleep deprivation... Read More
THE RISKAccumulation of acids in your body, due to insufficient... Read More
Depression is a serious issue. There are simply hundreds of... Read More
On February 3, 2005 the U.S. Food and Drug Administration... Read More
Depression is a mental state marked by melancholy, pessimism or... Read More
Having lived with a depressed partner for 3 years and... Read More
"Thanks for Noticin' Me" says Eeyore. He walks slowly. He... Read More
Depression is a problem that faces many of us, young... Read More
Depression has long been considered a character flaw indicative of... Read More
Depression can have many, many faces. If you are not... Read More
A zoo attendant entered a lion cage carrying only a... Read More
I heard about a woman who was suffering from depression,... Read More
Everyone feels down or blue once in awhile. Especially during... Read More
Looking to improve your mood?Edward W. Smith, motivational speaker, author... Read More
1.Remember that it is an illness:Clinical depression often requires medical... Read More
Market surveys on women, men and depression suggest an estimated... Read More
While war and poor economic conditions begin to affect people... Read More
Lifetime Prevalence of Depression and the Age-of-Onset Report Distributions of... Read More
I attended the Vagus Nerve Stimulation Therapy Conference at the... Read More
It seems unreal, another major storm hitting Florida after experiencing... Read More
The cover of the March 7, 2005 issue of Business... Read More
We all suffer with bad moods from time to time.... Read More
When I first mention this to most people, they really... Read More
When a person undertakes a course of therapy through their... Read More
Winter time is depression time for many women. Perhaps it... Read More
There are several factors can lead to depression after heart... Read More
Since Dr Malcolm Peet, a consultant psychiatrist at Sheffield swallow... Read More
While war and poor economic conditions begin to affect people... Read More
IntroductionChange in social and economical states throughout the world although... Read More
Being lonely is a normal part of our everyday lives.... Read More
Looking to improve your mood?Edward W. Smith, motivational speaker, author... Read More
Vagus Nerve Stimulation for Chronic Treatment-Resistant Depression About Vagus Nerve... Read More
Countless number of patients and their family members have asked... Read More
I heard about a woman who was suffering from depression,... Read More
A new research study has again shown that a diet... Read More
Do you blame your past, your family, your partner, your... Read More
On June 2 at 8:00 pm ET, Reuters news service... Read More
Being lonely is a normal part of our everyday lives...... Read More
The Law of PermanenceSuicide is always a permanent solution to... Read More
There's a dangerous illness afflicting women everywhere across the nation.... Read More
Being lonely is a normal part of our everyday lives.... Read More
Not long ago, I attended a mastermind group. During the... Read More
The cover of the March 7, 2005 issue of Business... Read More
It has just been announced, after a study by a... Read More
Suresh was a worried person when he came to me... Read More
It may come in waves, it may control our lives.... Read More
I'm sure at times of deep crisis many of you... Read More
The manufacturer of the vagus nerve stimulator has begun face-to... Read More
Depression strikes most of us and it can make us... Read More
Many of us feel depressed at one time or another,... Read More
Within the next few weeks, the FDA is expected to... Read More
There is one very simple reason for all emotional depression.In... Read More
Depression is a mental state marked by melancholy, pessimism or... Read More
Music so strongly evokes emotional responses that it is being... Read More
In 1965, a chemist working to develop an ulcer drug... Read More
Psychological well-being is something that we all have a right... Read More
It seems unreal, another major storm hitting Florida after experiencing... Read More
Katie came as close as is possible to having it... Read More
Depression |