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.
God Bless trapedinliberalhell RIP my friend
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.
Very strange. >:-/
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.
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.
Isn't it a joke to call any kind of study involving a drug with significant side effects, "double blind"?
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.
I'll do that, Doc - I could never understand the rationale...
Oh they will soon enough.
No. It's considered the "gold standard" for FDA trials.
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.
The benefits by avoiding first pass metabolism through the liver are avoided, IIRC.
Read the adverse drug reactions reported with presumed to be placebos. Geniune adverse drug reactions personally interest me. Had them. Done that.
IMHO, it would be a better world without SSRI's and tranquilizers. Who the hell needs them.
My thoughts exactly. Who would use an MAOI where a second-generation SSRI is available?
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.
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.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.