Psycho-Babble Medication Thread 356642

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FDA says VNS device lacks data

Posted by jrbecker on June 14, 2004, at 15:46:02

official meeting of the FDA panel on VNS meets tomorrow (6/17)/....

BX UPDATE 1-US FDA staff says Cyberonics` device lacks data

June 14, 2004 13:39:23 (ET)

http://biz.yahoo.com/prnews/040614/dem011_1.html

WASHINGTON, June 14 (Reuters) - Cyberonics' (CYBX,Trade) VNS Therapy lacks enough data to show it is safe and effective for use in chronically depressed patients, U.S. Food and Drug Administration staff reviewers said in a preliminary report released on Monday.

"FDA has identified several concerns regarding whether the clinical data ... provides reasonable assurance that VNS is effective," the reviewers said in a report posted on the agency Web site.

Shares of Houston, Texas-based Cyberonics were up $1.06, or 5.76 percent, to $19.48 in afternoon trade on Nasdaq after soaring about 20 percent immediately after the report.

On Tuesday, Cyberonics faces a FDA panel of outside experts who will discuss whether to recommend the company's pacemaker-like device, called VNS Therapy, for depression.

Approval of the new use for the device is key to the company's growth prospects, analysts say.

Despite the concerns, A.G. Edwards analysts Jan Wald said the reviewers' simply stated questions were "viewed as positive."

But "the questions are so fundamental that they might belie how complicated a task Cyberonics has in convincing the panel that they do have a trial that can withstand scrutiny," Wald added.

In their report, the FDA reviewers said a "lack of systematically collected safety data" in one study also made it difficult to determine "whether the clinical data ... provide reasonable assurance that the device is safe."

VNS Therapy, which is surgically implanted to deliver electrical pulses to the brain, is already cleared for epilepsy.

(Additional reporting by Bill Berkrot in New York)

FDA panel gives recommended approval anyways

Posted by jrbecker on June 16, 2004, at 9:52:55

In reply to FDA says VNS device lacks data, posted by jrbecker on June 14, 2004, at 15:46:02

official FDA approval is now pending...

http://www.thestreet.com/stocks/biotech/10166168.html

Cyberonics Ignites on FDA OK

By TSC Staff
6/16/2004 8:30 AM EDT

Cyberonics (CYBX:Nasdaq - news - research) vaulted to the top of both volume and percentage gainer boards Wednesday morning after a Food and Drug Administration panel recommended approval of its pacemaker-like nerve stimulator for treatment of severe depression.

The stock, which was halted Tuesday ahead of the decision, was recently up $15.66, or 80%, to $35.35 on Instinet, trading more than half a million shares in the first 30 minutes.

Despite a fair amount of bearish ridicule in the run-up to the meeting, the FDA's Medical Device Advisory Committee voted 5-2 to recommend the VNS Therapy System in patients "experiencing a major depressive episode that has not had an adequate response to four or more adequate antidepressant treatment."

Cyberonics will have to change labeling to reflect advice that doctors and implanting surgeons have appropriate experience and adequate training with the device, and that patients be educated in its use. It will also have to set up a long-term registry of patients receiving the device.

The VNS consists of a generator and nerve stimulator electrode that delivers a mild, intermittent electrical signal to the vagus nerve in the left side of a patient's neck. The company believes that stimulation of the nerve "produces widespread and bilateral effects in parts of the brain implicated in epilepsy, depression, anxiety, memory ... and responsible for modulation of key neurotransmitters such as serotonin and norepinephrine."

Re: FDA panel gives recommended approval anyways

Posted by snapper on June 16, 2004, at 10:18:19

In reply to FDA panel gives recommended approval anyways, posted by jrbecker on June 16, 2004, at 9:52:55

cool. My mom just pointed out on ABC evening news, that it was or is being approved. I had thought that the FDA outright rejected it. Apparently this isn't the case. thanks for the info!
snapper

Has anyone had success with VNS? (nm)

Posted by poop'd-out on June 16, 2004, at 23:46:03

In reply to FDA panel gives recommended approval anyways, posted by jrbecker on June 16, 2004, at 9:52:55

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