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    Marsha Linehan, posted by Daniel

Daniel

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Excerpt from selegiline.com about EMSAM® (transdermal selegiline):

In December 2004, pharmaceutical firms Bristol-Myers Squibb and Somerset Pharmaceuticals announced they had entered into an agreement to distribute and commercialize EMSAM, the first transdermal treatment for major depression. If the FDA permits, the patch will be marketed in 2005 for both acute and long-term depressive disorder. The FDA's EMSAM "approvable" letter of February 2004 indicated that the efficacy data supported granting a product license. Such approval is by no means a foregone conclusion. It is claimed that EMSAM's pharmacokinetic and pharmacodynamic properties promote the inhibition of MAO-A and MAO-B in the CNS while avoiding significant inhibition of intestinal and liver MAO-A enzyme; but labeling discussions will inevitably focus on the prudence of tyramine dietary restrictions.

Related Articles/Links:
Transdermal Patch Could Herald Renewed Popularity for MAOIs
Future Drug Treatments for Depression, Anxiety, Sleep Disorders, and Psychosis
 

Daniel

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It seems EMSAM, the antidepressant MAO transdermal patch, may be available by Feburary 26th, 2006:

Somerset Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Division of Psychopharmacologic Drugs has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2006 for EMSAM® (selegiline transdermal system), an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder.

excerpt from Somerset Announces Revised FDA PDUFA Date for EMSAM - Yahoo
 

David Baxter

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I would assume this is intended for people who cannot tolerate SSRIs? Or have they found a way around some of the side-effects that plagued MAO inhibitors previously?
 

Daniel

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Or have they found a way around some of the side-effects that plagued MAO inhibitors previously?

Yes, they have:

Because Emsam is delivered through the skin and does not need to be ingested, its manufacturer is seeking to avoid the so-called “black box” warning for its lowest proposed dose of 20 milligrams.

...The drugmakers said clinical data on more than 2,500 Emsam patients showed the drug was well tolerated without any dietary changes.

One study, in which patients taking the drug were encouraged to eat as much aged cheese as possible found they ”could not eat enough to cause a significant increase in blood pressure,” the documents said.

“The benefit of providing a new MAOI at an effective dose --Emsam 20 mg -- that can safely be taken without dietary modifications ... outweighs the risk of inaccurate labeling that would discourage patients who would benefit from this medication,” the companies said.

“We agree that the 30 and the 40 milligrams should have the dietary modifications, and we don’t dispute that,” Watson Pharmaceuticals spokeswoman Patty Eisenhaur told Reuters on Monday.

FDA’s Dubitsky said people’s sensitivity to tyramine in foods can vary widely and said there is a “need for a wide safety margin.”

Proposed depression patch would need warning - Reuters (10/25/05)

However, it seems Emsam isn't going to be popular except for those who haven't responded well to SSRIs, SNRIs, Wellbutrin, Remeron, etc.:

Some analysts have set low expectations for the drug, which they expect will only be prescribed for hard-to-treat depression by psychiatrists rather than general physicians.

Proposed depression patch would need warning - Reuters (10/25/05)

BTW, the 20-mg dose will not have a black box warning:

In a 7-4 vote, the [FDA] panel said the low-dose version of Emsam could be used safely without the warning.

FDA reviewer Greg Dubitsky told panelists the overall results from the company's clinical trials showed no real safety problem, but risks can vary widely between patients and can change. "Over time a person's tyramine sensitivity is not fixed; it can vary quite a bit," he said.

Lower-dose depression patch is safe - US FDA panel
 

David Baxter

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Thanks for that information, Daniel. It will be nice to have another option - not everyone does well on SSRIs, as I'm sure you know.

You're still coming up with consistently good posts. Are you and HeartArt still working on that Encyclopedia of Mental Health? ;o)
 

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