Depression Patch Approved, to be Sold as Emsam
Federal regulators in the US have approved the world’s first antidepressant skin patch, the selegiline transdermal patch, to be marketed under the name ‘Emsam’. The drug, first approved in the 1980s to help treat Parkinson’s disease, belongs to a category of less frequently used antidepressants prone to interactions with a substance called tyramine. The antidepressant patch will carry a ‘black box’ warning from the FDA.
Following the methylphenidate transdermal patch for ADHD (see our earlier articles “Success for New ADHD Patch” and “ADHD Patch to be Sold as Daytrana”), the latest drug and patch delivery system to receive FDA approval is the selegiline transdermal patch for the treatment of depression.
According to a story carried by the APA’s PsycPort, the antidepressant skin patch was approved on Tuesday and will be marketed under the name ‘Emsam’. The APA article highlights the risks of drugs which fall into the same category as Emsam, the monoamine oxidase inhibitors (MAOIs):
Although health officials say MAOIs are safe when used correctly, the drugs can cause dangerous interactions, including sudden and severe rises in blood pressure that can lead to a stroke, when patients consume food or drinks that contain a substance called tyramine - found in draft beer, red wine, fava beans, salamis, aged cheeses, soy sauce and other products.
However, the news release provided directly by the FDA specifically mentions that:
The once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression.
“Emsam provides a significant advance because at least in its lowest dose patients can use the drug without the usual dietary restrictions associated with these types of drugs known as MAO inhibitors,“ said Dr. Steven Galson, Director for the Center for Drug Evaluation and Research.
The FDA news release continues:
MAO inhibitors usually require specific dietary restrictions because when combined with certain foods they can cause a sudden, large increase in blood pressure, or “hypertensive crisis”. A hypertensive crisis can lead to a stroke and death. Symptoms of a hypertensive crisis include sudden onset of severe headache, nausea, stiff neck, a fast heartbeat or a change in the way your heart beats (palpitations), sweating, and confusion. Patients who have these symptoms should get medical care right away.
The lowest dose of the MAOI patch, which delivers 6 milligrams (mg) of the medication over a 24 hour period, can be used without such dietary restrictions.
The FDA reports that the only common side effect of Emsam detected in placebo-controlled trials was a mild skin reaction where the patch was placed. The antidepressant patch will be made available in three sizes that deliver 6, 9, or 12 mg of selegiline per 24 hours.
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This article was last reviewed by on Wednesday, 1st March 2006. You can leave a response below.
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19th March 2006
Finally! A “safer” MAO that my doctor is willing to prescribe! I hope it works as well as the Nardil did and doesn’t stop working after a few years as the Nardil also did.
10th July 2006
I live in the UK and have declined my psychiatrist’s advice to commence MAOI’s. Now that there is a possibility of this much safer method, the patch, I am interested. I’m not sure if it will be available in UK - does anyone know, please?
17th July 2006
Hi Mary,
I haven’t heard anything myself about whether Emsam / selegiline will be made available in the UK. I have seen some extraordinary prices quoted for Emsam in the US, though (circa $400 per month), so I wonder whether NICE would be slow to approve it for use by the NHS?
All the best,
Greg
20th February 2008
I have had severe mental health issues all of my life, but typical anti-depression meds don’t work for me. I asked my doctor about the patch but was refused.
20th February 2008
I can’t seem to keep a job or to get along with co-workers. I’m usually in a very hostile mood and tend to snap out at people for no good reason. My wife and kids left me a few years ago and I was let go from my job shortly thereafter after lying to my boss and in an official investigation.
I’ve taken several medications but nothing seems to help. I live in a rural community in Woodsfield Ohio where everyone knows everyone. I’m frequently abused because of my sexual prefrences. Maybe the patch would help get me strightened out. Any advice would be appreciated.