Acne Information

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.








MORE RESOURCES:

Acne: Prestige Beauty's New Bull's-Eye Posted Sep 5, 2008
Women's Wear Daily - 1 hour ago
by Molly Prior Prestige beauty firms are raising an issue with raised red bumps — notoriously referred to as acne — and increasingly are adding ...


Escalate firepower to win the acne war
SouthCoastToday.com, MA - 20 minutes ago
Fighting acne involves conducting warfare on many fronts. One front is the overproduction of male hormone that occurs in puberty and at other stages of life ...


Best Syndication

Acne - The Aftermath of Acne Breakouts
Best Syndication, CA - 13 hours ago
If you suffered from acne, you would know that severe acne like cystic lesions could create scarring, redness and pigmentation. If the acne was not treated ...


Steroid abuse acne scars are a real eyesore
Irish Medical Times, Ireland - Sep 3, 2008
The BBC reported that while mild doses can cause slight acne, this man used such severe doses the rash over his back and chest ulcerated. ...


Condom Lubricant Used as Acne Cure in Cambodia
FOXNews - Aug 29, 2008
A condom lubricant produced by a health organization to protect sex workers and gay men is being hailed as an acne cure by some in Cambodia, ...


Michala Banas Joins Celebrity Cast Supporting Acne Treatment ...
Free press releases (press release), UK - Sep 1, 2008
McLeod’s Daughters actress Michala Banas becomes new face of acne management treatment, Proactiv Solution. Popular Australian celebrity Michala Banas has ...


Best Syndication

Acne Does Not Choose - Be it a Man or a Woman
Best Syndication, CA - Sep 1, 2008
You see television programs about acne, you read articles about acne, and the internet is loaded with information about acne. Despite all these knowledge, ...


Acnecentre.com Launched With A New Key For Acne Fetters
PR Web (press release), WA - Sep 1, 2008
Acnecentre -- A new acne and skin care advice portal now works on the latest medical ideas to help teens and adults from acne hazards. ...


Study Outlines Teens' Preferences And Trade-offs For Freedom From Acne
Science Daily (press release) - Aug 20, 2008
20, 2008) — Teens report that they would pay about $275 to have never had acne, and are willing to pay considerably more to be acne-free than to have 50 ...


Photo retouching service zaps age lines, acne and more
Tribune Review, PA - Sep 1, 2008
For $7 per photo, his staff of five designers would remove acne and age spots, smooth out crows feet and age lines, even out skin tone and reduce shininess. ...

Acne - Google News

Home | Site Map  Copy Right 2006 Mahavir.com
NISL | Herbal Acne Solutions | Promotion Factory | Web Design | Online University Degree | College & University | GtpInfo | VPayU