EMSAM

  EMSAM^® (selegiline transdermal system) is a transdermal patch using the monoamine oxidase inhibitor (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.^[1] On February 28, 2006 the FDA approved EMSAM for the treatment of clinical depression. ^{[2] [3] [4]}

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Inception & Development

EMSAM's development was spearheaded by Alexander J. Bodkin, M.D. ^[5], Director of the Clinical Psychopharmacology Research Program at McLean Hospital in Belmont MA, in conjunction with Harvard Medical School. ^{[4] [6] [7] [8]} 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."^[1] The primary advantage of delivering selegiline in this manner is to bypass the gastrointestinal tract and liver, specifically the small intenstine, thereby limiting the chance of hypertensive crisis (very high spike in blood pressure possibly leading to stroke).^{[1] [9] [10]}

"Despite long-standing concerns over hypertensive reactions,... (MAOIs) have grown in popularity... (and) the risk of hypertensive episodes is less than 1%."^[11]

Food Intake Restrictions

The dietary problem was first discovered by a neurologist whose wife was taking an MAO inhibitor. After eating hard cheese, which is rich in tyramine, she would get severe headaches; thus, her husband's discovery of these spikes in blood pressure. For this reason, the crisis is still called the "cheese syndrome", even though other foods can cause the same problem.

When an MAOI is taken orally, and an individual ingests such tyramine rich foods, the body can not properly regulate the additional tyramine. Therefore, dietary modifications are necessary. Foods containing considerable amounts of tyramine include: air dried, aged and fermented meats, sausages and salamis; pickled herring; any spoiled or improperly stored meat, poultry and fish; spoiled or improperly stored animal livers; broad bean pods (fava beans); all tap beers, and other beers that have not been pasteurized; concentrated yeast extract (such as Marmite); most soybean products (including soy sauce and tofu); aged cheeses (not processed cheese); sauerkraut; and over-the-counter supplements containing tyramine. ^{[7] [12] [13][14][15]}

EMSAM Advantages

Due mainly to the availiability 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^{[1][11] [16] [17]} 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^[2]

In addition to the lack of dietary restrictions at the 6mg/24h dose, EMSAM offers^[10] another benefit. It is a continuous delivery system, keeping the medication at a steady level in the body over time.^[18] Generally, oral medication can not keep a steady dose in the blood stream.

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

Usage

The patch is changed once daily. There may be a reaction to the adhesive on the skin at the site of application.^[19] Patients are encouraged to use an adhesive remover: usually mineral oil, Vaseline^® or an over-the-counter product such as dermatology recommended TRIAD^® brand adhesive tape remover pads. 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.^[20]

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.^[4] 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 ^[21] include: (SSRIs), (SNRIs), (TCAs), other MAOIs, mirtazapine, bupropion, meperidine, analgesics such as tramadol, methadone, propoxyphene, cyclobezaprine and oral selegiline.^[4] 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.^[4]

Patients taking EMSAM should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.^[4]

EMSAM Name Origin, Manufacturer & Distributor

The acronym EMSAM is derived from the names Emily and Samuel. They are the children of Mel Sharoky, M.D., CEO of EMSAM's manufacturer, Somerset Pharmaceuticals, Inc.,^[22] The prescription medication is distributed by Bristol-Myers Squibb out of Princeton NJ

• NIH Medline Information: Serotonin Syndrome

References