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First Skin Patch to Treat Depression
Forbes.com ^ | 03.01.06 | NA

Posted on 03/01/2006 10:46:08 PM PST by neverdem

WEDNESDAY, March 1 (HealthDay News) -- The first transdermal patch to treat depression has been approved by the U.S. Food and Drug Administration.

The FDA approval was based on results of two double-blind, placebo-controlled studies of Emsam. One study found that six weeks of treatment with Emsam was more effective than a non-medicinal placebo in relieving symptoms of major depression disorder in adults, United Press International reported.

The once-a-day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. Emsam is designed to interact with three brain neurotransmitters that are believed to play a role in depression. The patch is not approved to treat depression in patients 17 and younger.

The final FDA approval comes two years after the agency first said the patch was "approvable." However, concerns about potential interactions with food and beverages high in tyramine -- such as salami, aged cheese, beer, and wine -- contributed to the delay in Emsam gaining final approval, MarketWatch reported.

It's believed that Emsam's active ingredient -- selegiline -- could interact with tyramine and cause a sudden, rapid increase in blood pressure. The FDA said patients who use the higher dose patches -- 9 and 12 milligrams per 24 hours -- must be advised to avoid foods and beverages high in tyramine. Patients who use the lowest dose -- 6 milligrams -- do not require any dietary restrictions, MarketWatch reported.

More information

To learn more about depression, visit the National Institute of Mental Health.


TOPICS: Business/Economy; Culture/Society; Government; News/Current Events; US: District of Columbia; US: Maryland
KEYWORDS: depression; emsam; happypatch; health; maoi; medicine; parkinsonsdisease; selegiline
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Regulators Approve Patch to Treat Depression AP via NY Times
1 posted on 03/01/2006 10:46:09 PM PST by neverdem
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To: neverdem

God Bless trapedinliberalhell RIP my friend


2 posted on 03/01/2006 10:53:53 PM PST by al baby (Father of the Beeber)
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To: El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; ..
A cancer treatment you can't get here

Soft drinks found to have high levels of cancer chemical

Stem Cells May Be Key to Cancer

A Billion Stars Hiding in Milky Way

FReepmail me if you want on or off my health and science ping list.

3 posted on 03/01/2006 11:02:39 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
Something I've wondered: Why do all those anti-depression drugs always say that they take six weeks before they have any effect??? It's supposed to be a neurotransmitter, or a stimulant for such. So it gets into the brain, and it should start doing something. Anything. Shouldn't it?

Very strange. >:-/

4 posted on 03/01/2006 11:14:50 PM PST by jennyp (WHAT I'M READING NOW: The Chicago Manual of Style, 14th ed.)
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To: jennyp
Why do all those anti-depression drugs always say that they take six weeks before they have any effect???

I'm not sure if it's all antidepressants, or just the selective serotonin re-uptake inhibitors, SSRIs, the current drugs of first choice for major depression. IIRC, it's probably a combination between the ability of the drugs to cross the blood-brain barrier and their metabolism and elimination by the liver and kidneys, respectively. But I'm just a FP doc, out of training for a while. I prefer to have a psychiatric consult for the patient if possible.

5 posted on 03/01/2006 11:53:49 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem
One study found that six weeks of treatment with Emsam was more effective than a non-medicinal placebo in relieving symptoms of major depression disorder in adults

Ain't that, like, common sense? ANY drug might be more effective than the placebo?

6 posted on 03/02/2006 12:38:24 AM PST by Old Sarge (Fobbit = REMF ... how do you like me now?)
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To: Old Sarge
Ain't that, like, common sense? ANY drug might be more effective than the placebo?

No. If the latest recieved wisdom always confirmed common sense they would not have had to develop double blind, placebo controlled trials of drugs for specific diagnoses. Check out the placebo effect by entering those terms at PubMed.

7 posted on 03/02/2006 1:05:52 AM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

Isn't it a joke to call any kind of study involving a drug with significant side effects, "double blind"?


8 posted on 03/02/2006 1:17:13 AM PST by HiTech RedNeck
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To: neverdem

The side effects of the patch form couldn't be worse than that of the pill form.

Why of all medications, an MAO inhibitor as the first patch form. I would have expected to see a Prozac patch.


9 posted on 03/02/2006 1:18:56 AM PST by HiTech RedNeck
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To: neverdem

I'll do that, Doc - I could never understand the rationale...


10 posted on 03/02/2006 1:32:03 AM PST by Old Sarge (Fobbit = REMF ... how do you like me now?)
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To: neverdem
I am surprised that the usual freeper nay sayers have not yet arrived to tell us that depression is a character flaw not a disease.
11 posted on 03/02/2006 1:38:00 AM PST by Straight Vermonter (Check out Mrs SV's webpage---> http://www.wayoftears.com)
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To: Straight Vermonter

Oh they will soon enough.


12 posted on 03/02/2006 1:43:27 AM PST by HiTech RedNeck
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To: HiTech RedNeck
Isn't it a joke to call any kind of study involving a drug with significant side effects, "double blind"?

No. It's considered the "gold standard" for FDA trials.

13 posted on 03/02/2006 2:02:23 AM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

At the risk of feeling like the child declaring the emperor's nakedness... a patient who gets a drug with a marked side effect isn't going to have to guess.


14 posted on 03/02/2006 2:05:23 AM PST by HiTech RedNeck
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To: HiTech RedNeck
The side effects of the patch form couldn't be worse than that of the pill form.

The benefits by avoiding first pass metabolism through the liver are avoided, IIRC.

15 posted on 03/02/2006 2:07:04 AM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: HiTech RedNeck
At the risk of feeling like the child declaring the emperor's nakedness... a patient who gets a drug with a marked side effect isn't going to have to guess.

Read the adverse drug reactions reported with presumed to be placebos. Geniune adverse drug reactions personally interest me. Had them. Done that.

16 posted on 03/02/2006 2:18:09 AM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

IMHO, it would be a better world without SSRI's and tranquilizers. Who the hell needs them.


17 posted on 03/02/2006 3:28:21 AM PST by CalvaryJohn (What is keeping that damned asteroid?)
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To: HiTech RedNeck
Why of all medications, an MAO inhibitor as the first patch form?

My thoughts exactly. Who would use an MAOI where a second-generation SSRI is available?

18 posted on 03/02/2006 3:31:42 AM PST by Petronski (I love Cyborg!)
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To: HiTech RedNeck

MAO's have so many horrible side effects that the market is really restricted. So, the makers, are trying to sell this in a different form. Prozac is selling fine in pill form for now.


19 posted on 03/02/2006 4:25:33 AM PST by dalight
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To: Petronski

Who would use an MAOI where a second-generation SSRI is available?

Because that drug works best for them. Finding the right anti-depressant for an individual is a lot like going to the shoe store and finding a comfortable pair of shoes that fit.

20 posted on 03/02/2006 5:01:19 AM PST by elli1
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