Drugs Xagena
The FDA ( Food and Drug Administration ) approved Emsam ( Selegiline ), the first transdermal patch for use in treating major depression.
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.
Major depressive disorder is a common psychiatric condition in the U.S. population.
Symptoms of depression include general emotional dejection, withdrawal and restlessness that interfere with daily functioning, such as loss of interest in usual activities; significant change in weight and/or appetite; insomnia; increased fatigue; feelings of guilt or worthlessness; slowed thinking or impaired concentration; and a suicide attempt or suicidal ideation.
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 palpitations, sweating, and confusion.
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The lowest dose of the MAOI patch, which delivers 6 mg of the medication over a 24 hour period, can be used without such dietary restrictions.
The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of Selegiline per 24 hours.
The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.
Emsam has been shown safe and effective for treatment of major depressive disorder in two 6-8 week studies and also in a longer-term study of patients.
The data for EMSAM 6mg/24hr support the recommendation that a modified diet is not required at this dose.
Patients are advised to change the patch once a day.
The more limited data available for Emsam 9mg/24hr and 12mg/24hr do not rule out food effects so that patients receiving these higher doses should follow dietary restrictions that advise them to avoid certain foods or beverages. This includes foods and beverages such as aged cheese and wine.
The only common side effect of Emsam detected in placebo-controlled trials was a mild skin reaction where the patch is placed. There may be mild redness at the site when a patch is removed. If the redness does not go away within several hours after removing the patch or if irritation or itching continues, patients are advised to contact their doctor.
Another side effect that was seen less commonly was light-headedness related to a drop in blood pressure.
Source: FDA, 2006
XagenaMedicine_2006
