# Antidepressant transdermal patch may launch this year



## Daniel (Feb 22, 2005)

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


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## Daniel (Dec 14, 2005)

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 EMSAMÂ® (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


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## David Baxter PhD (Dec 14, 2005)

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?


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## Daniel (Dec 14, 2005)

> 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 â€œblack boxâ€ 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.
> 
> ...



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


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## David Baxter PhD (Dec 15, 2005)

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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