Emsam

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Skeletal formula of selegiline
Skeletal formula of selegiline

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]

Contents

[edit] Inception & Development

Emsam's development was spearheaded by J. Alexander, 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 intestine, 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]

[edit] 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]

[edit] 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[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, although there is no evidence that this makes a difference in terms of the efficacy or side effects of this medication.[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).

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, increased appetite, and increased severity of depressive symptoms towards the end of the day.

[edit] 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]

[edit] 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]

[edit] 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

[edit] External links

  • Everything You Ever Wanted to Know about EMSAM and more. [1]
  • FDA Approves Emsam (selegiline) as First Drug Patch for Depression. |[2]
  • Andrew Bridges, Associated Press (2006). "Skin patch for mood disorders approved". The Boston Globe March 01, 2006 |[3]
  • Bodkin JA, Amsterdam JD (2002). "Transdermal Selegiline in Major Depression: A Double-Blind, Placebo-Controlled, Parallel-Group Study in Outpatients". American Journal of Psychiatry 159:1869-1875,November 20
  • Bristol-Myers Squibb Company EMSAM information for U.S. residents only. [4]
  • Hitti, Miranda (reviewed bt Chang, M.D. Louise) (28-02-2006). ""FDA OKs Patch to Treat Depression,

Using EMSAM in Lower Doses May Avoid Concerns About Drug Interactions"". Medicine Net.com. 

  • Tong TG, Saklad SR (1994). "What foods you should avoid on MAOIs" (MAO-I's Dietary Restrictions) [5]
  • Walker SE, Shulman KI, Tailor SA, Gardner D (October 1996). "Tyramine Content of Previously Restricted Foods in Monoamine Oxidase Inhibitor Diets". Journal of Clinical Psychopharmacology © Williams & Wilkins. All Rights Reserved. (5): 383–388. PMID 8889911.  [6]
  • William J. Cromie (November 7, 2002). "Bodkin is patching up depression". Harvard University Gazette (photo of Dr. Bodkin displaying patch.)[7]
  • Feiger AD, Rickels K, Rynn MA, Zimbroff DL, Robinson DS (2006). "Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial". J Clin Psychiatry Sep; 67(9): 1354-61. [8]
  • Framton JE, Plosker GL (2007). "Selegiline transdermal system: in the treatment of major depressive disorder". Drugs 67(2): 257-65; discussion 266-7. [9]
  • Patkar AA, Pae CU, Masand PS (2006). "Transdermal selegiline: the new generation of monoamine oxidase inhibitors". CNS Spectrums May;11(5): 363-75. [10]
  • Patkar AA, Pae CU, Zarzar M (2007). "Transdermal selegiline." Drugs of Today (Barcelona, Spain) Jun; 43(6): 361-77. [11]
  • NIH Medication Information: EMSAM.

[edit] References

  1. ^ a b c d Patkar AA, Pae CU (May 2006). "Transdermal selegiline: the new generation of monoamine oxidase inhibitors". CNS Spectrum 11 (5). PMID 16641841. 
  2. ^ a b Cruzan, Suzanne (28 February 2006). "FDA Approves EMSAM (Selegiline) as First Drug Patch for Depression". U.S. Food and Drug Administration, FDA News P06-31. 
  3. ^ Andrew Bridges, Associated Press (March 01, 2006). "Skin Patch for Mood Disorders Approved". The Boston Globe. 
  4. ^ a b c d e f "FDA Approves EMSAM(R) (selegiline Transdermal System), The First Transdermal Patch For The Treatment Of Major Depressive Disorder" (06 Mar 2006). Medical News Today. 
  5. ^ Alexander J. Bodkin, M.D.. Retrieved on 2007-09-08.
  6. ^ Frampton JE, Plosker GL (2007). "Selegiline transdermal system: in the treatment of major depressive disorder". Drugs 67 (2): 257–67, discussion 266-7. PMID 17284087. 
  7. ^ a b Tong TG, Saklad SR (1994). "What foods you should avoid on MAOIs (MAO-I's Dietary Restrictions)". 
  8. ^ William J. Cromie (2002-11-07). Bodkin is Patching up Depression. Retrieved on 2007-09-08.
  9. ^ Hypertensive Crisis. Retrieved on 2007-09-15.
  10. ^ a b Rapaport MH (2007). "Dietary restrictions and drug interactions with monoamine oxidase inhibitors: the state of the art". Journal of Clinical Psychiatry 68 (8). PMID 17640157. 
  11. ^ a b Lavin MR, Mendelowitz A, Kronig MH (August 1, 1993). "Spontaneous hypertensive reactions with monoamine oxidase inhibitors". Biological Pysychiatry 34 (3). PMID 8399806. 
  12. ^ "Continuous Delivery for Once-Daily Application" (June 2007). Bristol-Myers Squibb. 
  13. ^ Walker SE, Shulman KI, Tailor SA, Gardner D (1996 October). "Tyramine content of previously restricted foods in monoamine oxidase inhibitor diets". Journal of Clinical Psychopharmacoly 16 (5): 383–8. PMID 8889911. 
  14. ^ Feinberg SS, Holzer B (June 1997). "Feinberg SS, Holzer B". Journal of Clinical Psychopharmacology 17 (3). PMID 9169971. 
  15. ^ Wing YK, Chen CN (June 1997). "Wing YK, Chen CN". Journal of Clinical Psychopharmacology 17 (3). PMID 9169972. 
  16. ^ Fiedorowicz JG, Swartz KL (July 2004). "The role of monoamine oxidase inhibitors in current psychiatric practice". Journal of Psychiatric Practice 10 (4). PMID 15552546. 
  17. ^ Krishnan KR (2007). "Revisiting monoamine oxidase inhibitors". Journal of Clinical Psychiatry 68 (8). PMID 17640156. 
  18. ^ Patkar AA, Pae CU, Zarzar M (June 2007). "Transdermal selegiline" 43 (6). PMID 17612708. 
  19. ^ Frampton JE, Plosker GL (2007). "Selegiline transdermal system: in the treatment of major depressive disorder". Drugs 67 (12). PMID 17284087. 
  20. ^ Feiger AD, Rickels K, Rynn MA, Zimbroff DL, Robinson DS (September 2006). "Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial". Journal of Clinical Psychiatry 67 (9). PMID 17017821. 
  21. ^ Serotonin Syndrome. Retrieved on 2007-09-15.
  22. ^ Somerset Pharmaceuticals, Inc. Tampa FL 33607 USA