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.
Well, yes. But the side-effect profile of an MAOI is gigantic, so it seems odd to me that they chose an MAOI for a new transdermal system.
Who the hell needs them? Do you also ask why the hell should a diabetic need insulin?
Why of all medications, an MAO inhibitor as the first patch form?
I'm not familiar with this particular medication but the reason could possibly be to minimize side affects (like stomach upset). Another reason is that a patch would be a 'sustained released' version of the med. (Effexor & Wellbutrin, for example, are now available in sustained release capsule forms.) The advantages being once daily convenience and even levels of the drug in the bloodstream. Another possibility might be that a patient will be able to use a lower doseage--another bonus for limiting side effects.
The fact that it takes at least several weeks for an antidepressant to start working shows, to me at least, that the change in concentration of brain chemicals is not the reason antidepressants work.
See my Post #23.
Very well. Thanks.
It makes sense to me now.
Selegiline is generally very well tolerated. Because it is metabolized to amphetamine derivatives, it is typically administered in the morning and at midday rather than in the evening to minimize the potential for insomnia. Some patients experience gastrointestinal side effects. Unusual side effects include increased liver enzymes and aggravation of peptic ulcer disease.
Could very well be that trans-dermal administration minimizes side effects and is easier on the tummy.
Popular Antidepressants Boost Brain Growth, Hopkins Scientists Report (maybe)
As an aside, it req'd something like + - 100 years to figure out exactly how aspirin works.
Wouldnt an more effective way to dispurse this drug be by dart? Then we could start a urban program starting in the skid row areas and hire gang bangers that you gotta admit, already enjoy shooting people, to shoot the people on the streets that could use a little lift. We could set up point values and form fantasy leagues...... hmmm maybe there should be limits to my imagination...
About four hours and thirty-five minutes.
I haven't read all the remarks yet, so excuse if this has already been covered. Is this drug for all types of depression, thus would include bi-polar conditions?
Off topic, but what about Zicor for cholesterol? My son insists I not take my prescription. He said the head/owner of the hospital in Tonopah advises against it. I keep forgetting to ask my daughter and/or my doctor.
Joke from my doctor daughter today:
How many surgeons it takes to screw in a lightbulb. One, but he expects the whole world to revolve around him!
Do you know what does it means when a doctor has a thermometer in her hand? Some a**whole has her pen.
BTW, I don't always comment on the threads you alert us to. But I did want to thank you once again for your efforts. Appreciated.
IIRC, this patch is the third or fourth choice because of some adverse food-drug interactions, for major depressive disorder, not manic depression, aka bi-polar. But I'm not a psychiatrist.
Off topic, but what about Zicor for cholesterol? My son insists I not take my prescription. He said the head/owner of the hospital in Tonopah advises against it. I keep forgetting to ask my daughter and/or my doctor.
Natural substance lowers cholesterol better than statins
Check comment 40 on that thread too. I found a paper on it.
My mom takes Zocor. Like all statins, you need liver function blood tests periodically when you first start them for at least a few months. You also must stay on guard for unexplained muscle pain or weakness while you still take them.
This thread prompted me to e-mail my daughter. She answered in two words: TAKE IT
Thank you for that mention of liver tests. My doctor has not had that done for me - unless it is part of the labs she takes on a regular basis. I hope I can remember to ask her. Thanks again for telling me about it. I'm probably okay, because I don't experience weakness.
One time I chewed on some sugar cane. It was pithy, not sweet. Must have been old or something. Pecan pralines are much better. :0)
Thanks, that's fascinating! If that's true, then it would suggest that depression takes a long time to develop as well. I suppose it would also suggest that certain kinds of mental exercises or activities (as opposed to others or none at all) would help prevent depression in the first place. I wonder.
How long before somebody on the patch goes on a rampage and the lawyers sue the manufacturer out of existence?
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