Emsam

Emsam (selegiline transdermal system) is the trade name of an antidepressant of the monoamine oxidase inhibitor (MAOI) class. Emsam is a transdermal patch containing the MAOI selegiline. Selegiline, in small doses, is most commonly used in the treatment of Parkinson's disease. It is also effective in higher doses for the treatment of major depressive disorder. On February 28, 2006 the U.S. Food and Drug Administration (FDA) approved EMSAM for the treatment of major depression.

Inception and development
Emsam's development was spearheaded by J. Alexander Bodkin, M.D., Director of the Clinical Psychopharmacology Research Program at McLean Hospital in Belmont MA, in conjunction with Harvard Medical School. Currently, it is the only MAOI on the market used in the treatment of depression that is absorbed through the skin into the blood stream and thereby to the central nervous system.

The patch "is a matrix containing three layers consisting of a backing, an... adhesive drug layer, and a release liner that is placed against the skin." The primary advantage of delivering selegiline in this manner is to bypass the gastrointestinal tract and liver, specifically the small intestine, thereby limiting the chance of hypertensive crisis (very high spike in blood pressure possibly leading to stroke).

"Despite long-standing concerns over hypertensive reactions,... (MAOIs) have grown in popularity... (and) the risk of hypertensive episodes is less than 1%."

Emsam advantages
Due mainly to the availability of the newer SSRIs and SNRIs, which are viewed to have more medically benign side effects in the treatment of depression, psychopharmacologists and psychiatrists have avoided prescribing MAOIs because of the possibility of hypertensive crisis. With Emsam, taken at the lowest dose of 6 mg. every 24 hours, no dietary modifications are required by the FDA, and the chance of such a side effect due to diet is eliminated. The FDA requirement for dietary modifications for the 9 mg and 12 mg doses are based on theoretical concerns, as no adverse events due to diet have ever been reported.

In addition to the lack of dietary restrictions at the 6 mg/24h dose, Emsam offers another benefit. It is a continuous delivery system, keeping the medication at a steady level in the body over time, although there is no evidence that this makes a difference in terms of the efficacy or side effects of this medication. Generally, oral medication can not keep a steady dose in the blood stream.

Emsam is also valuable in the treatment of atypical depression, which is not alleviated by the more commonly used selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reupatake inhibitors (SNRIs) and tricyclic antidepressants (TCAs).

Somewhat surprisingly, clinical trials done with MAOIs do not find that they are more effective than other antidepressants when they are tested in large groups of people. However, for certain individuals, especially individuals who have not done well on other antidepressants, an MAOI may be best. MAOIs are thought to be particularly effective in what has been called "atypical" depression. Atypical depressions are characterized by an increased need for sleep and increased appetite.

Usage
The patch is changed once daily. There may be a reaction to the adhesive on the skin at the site of application. Patients are encouraged to use an adhesive remover: usually mineral oil, Vaseline or an over-the-counter product such. A new patch is placed on a different site. The combination of adhesive remover, and placing each patch on a new area of skin, is to discourage any dermatological reason for discontinuance of the patch.

Using rubbing alcohol or hydrogen peroxide to clean the skin of oils and dirt before applying a patch can increase the likelihood of proper attachment for the duration of each 24 hour period. Immediately after applying a patch it can be helpful to use the pressure and body heat of the palm of the hand to enhance proper adhesive contact.

All of the dietary restrictions are currently required by the FDA, as a precaution, at the higher 9 mg/24h and 12 mg/24h doses of Emsam.

Medication interactions
Over-the-counter items that can not be used while on Emsam include: St. John's Wort; products containing dextromethorphan such as cough and cold preparations; decongestant medicines; and diet pills or herbal weight loss products. Caffeine and chocolate can only be consumed in small amounts.

There are prescription medications that can not be taken while using Emsam, and for 2 weeks after stopping Emsam. Some medications must not be taken for 1 week (or more) before an individual can start using Emsam.

Medications that can not be taken because they can cause serotonin syndrome include: (SSRIs), (SNRIs), (TCAs), other MAOIs, mirtazapine, analgesics such as  meperidine, tramadol, methadone, propoxyphene, cyclobenzaprine, and oral selegiline. The use of Emsam is contraindicated for use with sympathomimetic amines, including amphetamines as well as cold products and weight-reducing preparations that contain vasoconstrictors (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine). Carbamazepine and oxcarbazepine are also contraindicated.

Patients taking Emsam should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.

Name origin, manufacturer and distributor
The acronym Emsam is derived from the names Emily and Samuel. They are two of the children of Mel Sharoky, M.D., CEO of Emsam's manufacturer, Somerset Pharmaceuticals, Inc., The prescription medication is distributed by Bristol-Myers Squibb out of Princeton, NJ.