This was welcomed by clinicians who hoped that EMSAM would be better tolerated than oral MAOIs and non- MAOI antidepressants, as well as being effective for treatment in a wide spectrum of depressed patients including atypical depression, bipolar depression, and refractory depression. Unfortunately, the clinical use of EMSAM has been underutilized and its potential usefulness overlooked. This article suggests that fear of possible side effects, particularly the “cheese reaction” and serotonin syndrome, are some of the main contributors to underutilization by clinicians. These risks have been significantly exaggerated with the 6 mg/day dose not even requiring a special diet. Other contributing factors leading to underutilization are reviewed such as: the lack of studies addressing many important clinical questions; inadequate data analyses; not evaluating the effect of EMSAM on comorbid psychiatric conditions, particularly anxiety disorders; lack of antidepressant comparators versus EMSAM; no dose–response relationship examined; various depressive subtypes and conditions are unexplored, eg, bipolar depression and refractory depression; poor insurance coverage for an expensive medication; as well as minimal marketing efforts and postmarketing studies. On the other hand, many potential advantages of EMSAM are not highlighted enough in the literature and by pharmaceutical companies which might have increased clinical interest and utilization of the antidepressant. For example, the advantages of EMSAM include: avoidance of swallowing issues, as can be seen with oral antidepressants; minimal side effects, probably due to a favorable pharmacokinetic profile; minimal evidence of suicidal behavior, probably relating to the transdermal route of administration; low rates of inducing hypomanic/manic episodes; as well as significant efficacy in “anxious depression” and atypical depression. Recent efforts in conducting some post hoc analyses and presentations on EMSAM may yet stimulate further clinical interest and use of this antidepressant. Keywords: EMSAM patch, MAOI, tyramine- free diet. Introduction. This article reviews how and why EMSAM, a novel monoamine oxidase (MAO) inhibitor (MAOI) antidepressant, has been significantly neglected and underused by the medical community despite being US Food and Drug Administration (FDA)- approved for over 7 years. This approval was welcomed by academicians who believed that EMSAM would provide patients with the first antidepressant that had a new delivery system – a transdermal patch. This would minimize side effects and thus allow patients to more easily tolerate treatment with a highly effective class of antidepressants, the MAOIs. In the last decade, researchers have demonstrated that although the pharmacotherapeutic treatment of major depressive disorder (MDD) was frequently effective, less than half of patients failed to have a remission of their illness whilst taking routine antidepressants and, therefore, continued to suffer. This was most recently highlighted in the National Institute of Mental Health (NIMH)- sponsored STAR*D Study where only 4. SSRI), and only about 3. Furthermore, a relapse occurred in 4. These disappointing results for STAR*D and other antidepressant trials may be partially related to the inefficacy of antidepressants in many depressed patients but may also be related to patient noncompliance and medication side effects. Noncompliance is highly prevalent, occurring in as many as 6. Swedish Pain Services diagnoses and treats pain-related problems like headaches, back pain, arthritis, and fibromyalgia. Can You Take a Sleep Test at Home? The Latest Guidelines and Expert Advice. 1 Nicotine Replacement Therapy Guidance Document FINAL – October 29, 2012 Prescribing Nicotine Replacement and Managing Nicotine Withdrawal in Hospitalized Patients BACKGROUND An initial interim Nicotine Replacement Therapy. By Kerry GrensNEW YORK (Reuters Health) - Nicotine replacement therapy appears to be safe for people discharged from the hospital after suffering a h. Chantix is a prescription medication used to help people stop smoking. Unlike many other medications used for this purpose, this medication does not contain nicotine. The nicotine patch is a nonprescription medication used to. In the STAR*D study, over 5. In an attempt to improve efficacy and compliance of antidepressants and decrease their side effects, new antidepressants with different mechanisms of action, modifications to their structure, and alterations in the delivery system have been sought. Liquid preparations of various antidepressants (eg, escitalopram, fluoxetine, doxepin) and a disintegrating form of an antidepressant tablet (Remeron Soltab) that dissolves within the mouth in 4. Fluoxetine has been developed as a once- a- week tablet to increase compliance from missed doses from daily administrations. Paroxetine CR (controlled release) was developed to decrease gastrointestinal side effects, particularly nausea, by being absorbed more in the duodenum than the stomach. Lastly, intravenous antidepressants (eg, clomipramine, citalopram, amitriptyline) have been developed (used in Europe) to potentially increase efficacy and possibly induce a faster antidepressant response since this route theoretically avoids first- pass metabolism and has favorable pharmacokinetics. These studies have failed to show any clinical advantages in efficacy for these altered forms of antidepressants and those with different routes of administration, although compliance may have improved. Recently (2. 00. 8), EMSAM (. The transdermal delivery system was believed to offer a number of unique advantages. This mode of administration (transdermal) has provided for a beneficial pharmacokinetic profile, avoiding first- pass metabolism with gradual absorption over 2. EMSAM, at low doses, is a selective MAO- B inhibitor (MAOI- B); at the doses approved (6–1. MAO- A inhibitor (MAOI- A) and a MAOI- B. But since transdermal administration avoids direct gastrointestinal exposure and first- pass effects, there is no significant MAOI- A inhibition in the gut. A tyramine- free diet is unnecessary for the dose of 6 mg/2. FDA. 1. 0 The side effect profile for EMSAM 6 mg was no different than placebo except for an increased incidence of patch- site reactions (mild contact dermatitis). In summary, EMSAM has been shown to be a highly effective antidepressant for MDD (for acute and maintenance treatment) in double- blind placebo- controlled studies with a reduced risk of many of the side effects noted for oral MAOIs, particularly the “cheese reaction”. There have been three pivotal short- term (6–8 weeks), double- blind, placebo- controlled studies – two of these being a fixed dose of 6 mg. Interestingly, one of the short- term studies found drug–placebo differences starting as early as the end of week 1 of treatment, suggesting an early onset of action not usually seen with antidepressants. Thus, EMSAM is an alternative antidepressant that is highly effective and well- tolerated with a unique delivery system. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Boots NicAssist 14mg24 Hour Transdermal Patch Nicotine Step 2 7 Patches. Detailed product info, read reviews, buy online and earn advantage points. The need for alternative antidepressants is obvious. This is highlighted by the STAR*D study finding that failing to respond to one antidepressant does not preclude responding to subsequent antidepressants. Nonetheless, whether EMSAM offers any clinical advantages with its unique transdermal delivery system awaits clarification. The central question for our paper is why has EMSAM not been more widely prescribed by health professionals? This is even more bewildering since EMSAM is a MAOI, a class of drugs that may be one of the most effective of the antidepressants. Our review will also attempt to clarify the place of MAOIs, particularly EMSAM, in psychiatry. MAOIs were first developed in the late 1. MDD. Unfortunately, as a class of antidepressants, MAOIs have been misunderstood and underutilized. The discovery that MAOIs were effective in depression came by serendipity; a MAOI that was an effective antituberculosis drug, iproniazid, helped the depression of a patient with tuberculosis. Subsequent development and usage of other FDA- approved MAOIs for depression was accompanied with a number of patients having a hypertensive crisis, with some having strokes. These previously unrecognized adverse events led the FDA in 1. With the cheese reaction understood and the need for a tyramine- free diet (and also avoiding sympathomimetic drugs), MAOIs were reintroduced into psychiatry within a year after their discontinuation. Besides the need to restrict one’s diet, avoiding certain foods and medicines which might induce a serotonin syndrome was also a mandate. A nicotine patch is a device designed to deliver nicotine through the skin and into the blood stream. It is used to help prevent the craving for nicotine that smokers experience when attempting to quit. Nicotine replacement therapy (NRT) has been available in Australia for nearly 30 years and is the most widely used pharmacotherapy to help smokers quit. Nicotine replacement therapy is available as a nicotine patch, gum. Despite these restrictions, MAOIs have been found to be more effective than tricyclic antidepressants in the treatment of atypical depression. Whether MAOIs offer any advantage over SSRIs for atypical depression still remains unclear. MAOIs are not only helpful for atypical depression but also are effective for non- atypical depression. Mc. Grath et al found MAOIs were even effective in melancholia. Despite the efficacy of MAOIs in these conditions, clinicians generally recommend starting with SSRIs prior to considering a treatment course with an MAOI due to SSRIs’ ease of use, no concerns for restrictive diets, and minimal worries about interactions with other medications. MAOIs have also been recommended as one of the treatment strategies in drug- refractory depression. As reviewed by Mc. Grath et al, six studies (four double- blind and two open- label studies) assessed tranylcypromine, a MAOI, in refractory depression; response rates ranged from 2. Large- scale studies directly addressing this topic have been lacking. Recently, the STAR*D project evaluated the efficacy of tranylcypromine, an irreversible MAOI, in an open- label study in patients with an MDD who were treatment refractory to a 1. SSRI), and two subsequent antidepressant treatment trials, for their refractory state. These refractory patients were randomized to receive either tranylcypromine (n=5. The remission rate for tranylcypromine was not significantly different from the comparator (6. Furthermore, the mean dose at the end of the study was less than 3. Apparently, many of these refractory depressed patients were very sensitive to side effects of the MAOI, with 4. MAOI- treated patients discontinuing the drug due to adverse events in comparison to 2. P< 0. 0. 5). This sensitivity to adverse events in the MAOI group may also have led to the minimal dose received (patients could have been administered from 1. Interestingly, in a small study of depressed elderly patients (n=1. EMSAM patch. At this high oral dose, the selectivity of this compound for MAOI- B probably was lost.
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