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Emsam (Selegiline Transdermal) - Summary

 
 



Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of EMSAM or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised for the need for close observation and communication with the prescriber. EMSAM is not approved for use in pediatric patients. Furthermore, EMSAM at any dose should not be used in children under the age of 12, even when administered with dietary modifications. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

 

EMSAM SUMMARY

EMSAM® (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM is designed to continuously deliver selegiline over a 24-hour period.

EMSAM (selegiline transdermal system) is indicated for the treatment of major depressive disorder.

The efficacy of EMSAM in the treatment of major depressive disorder was established in 6- and 8-week placebo-controlled trials of outpatients with diagnoses of DSM-IV category of major depressive disorder (see Clinical Efficacy Trials).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempt or suicidal ideation.

The benefit of maintaining patients with major depressive disorder on therapy with EMSAM after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

The antidepressant action of EMSAM in hospitalized depressed patients has not been studied.


See all Emsam indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Emsam (Selegiline Transdermal)

Metabolic Disorders Linked to Severe, Refractory Depression
Source: Medscape Psychiatry & Mental Health Headlines [2017.01.12]
A large proportion of patients with severe, refractory depression have neurometabolic disorders that, once treated, appear to cause depressive symptoms to remit over the long term.
Medscape Medical News

OncoBreak: Cancer and Depression; Diagno$tic Te$t$; New Watson Study
Source: MedPage Today Gastroenterology [2017.01.12]
(MedPage Today) -- News, features, and commentary about cancer-related issues

New apps designed to reduce depression and anxiety as easily as checking your phone
Source: Anxiety / Stress News From Medical News Today [2017.01.09]
Soon you can seek mental health advice on your smartphone as quickly as finding a good restaurant.

ADHD and Depression: What's the Connection?
Source: ADHD / ADD News From Medical News Today [2016.12.29]
ADHD conjures up thoughts of hyperactivity and energy, but depression can also be a symptom. Find out how depression and ADHD are linked.

How to avoid Facebook-induced depression
Source: Depression News From Medical News Today [2016.12.29]
A review has been conducted to analyze the link between Facebook use and depression. The research has highlighted some ways to avoid 'Facebook depression.'

more news >>

Published Studies Related to Emsam (Selegiline Transdermal)

The relationship between depression and regional cerebral blood flow in Parkinson's disease and the effect of selegiline treatment. [2011.07]
OBJECTIVES: We examined the relationship between severity of depression in Parkinson's disease (PD) and regional cerebral blood flow (rCBF) using single photon emission computed tomography (SPECT) and the reaction to levodopa-selegiline combination therapy... CONCLUSIONS: These results indicate that selegiline controlled not only worsening of motor function and cognitive function in PD but also aggravation of minor depression, and restrained a fall in whole brain rCBF. (c) 2010 John Wiley & Sons A/S.

A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. [2010.03.01]
AIM: The primary aim of this study was to determine the safety and efficacy of the monoamine oxidase-B (MAO-B) inhibitor selegiline hydrochloride (SEL, l-Deprenyl; Eldepryl) as an aid for smoking cessation in cigarette smokers... CONCLUSIONS: Our results suggest that SEL was safe and well-tolerated by adult cigarette smokers, but did not improve smoking abstinence rates compared to PLO. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers. [2010]
l-Deprenyl; Eldepryl) as an aid for smoking cessation in cigarette smokers... CONCLUSIONS: Our results suggest that SEL was safe and well-tolerated by adult

Selegiline and oxidative stress in HIV-associated cognitive impairment. [2009.12.08]
OBJECTIVE: To assess the effectiveness of the selegiline transdermal system (STS) in reversing HIV-induced metabolic brain injury (as measured by proton magnetic resonance spectroscopy [MRS]) and in decreasing oxidative stress, measured by CSF protein carbonyl concentration... CONCLUSION: In this 24-week study, the selegiline transdermal system (STS) had no effect on either magnetic resonance spectroscopy (MRS) metabolites or oxidative stress, as measured by CSF protein carbonyl concentration. The lack of effect on these biomarkers is also reflected in the lack of cognitive improvement in the STS groups compared to placebo. Level of evidence: This study provides Class II evidence that STS had no effect on either MRS metabolites or oxidative stress, as measured by CSF protein carbonyl concentration over a period of 24 weeks.

Efficacy of selegiline add on therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study. [2008.03]
OBJECTIVE: It has been reported that selegiline, a Selective Monoamine Oxidase Inhibitor B (MAOI-B), at low doses would be helpful for treating negative symptoms in schizophrenia. Nevertheless, the results are contradictory so far. This study was designed to investigate the effect of selegiline added to risperidone as augmentation therapy in patients with chronic schizophrenia and prominent negative symptoms in an 8 week, double blind and randomized clinical trial... CONCLUSION: The present study indicates selegiline as a potential adjunctive treatment strategy for the negative symptoms of schizophrenia. Nevertheless, results of larger controlled trials are needed before recommendation for a broad clinical application can be made. (c) 2007 John Wiley & Sons, Ltd.

more studies >>

Clinical Trials Related to Emsam (Selegiline Transdermal)

Evaluation of Adhesion and Dermal Tolerability of EMSAM [Completed]

PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly [Completed]
Evaluate the effect of age on the PK of two different doses of EMSAM.

A Pilot Study Assessing EmSam in Bipolar Depression [Terminated]
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.

Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease [Completed]
Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2. 5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1. 25 mg for the first 6 weeks and a daily dose of 2. 5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2. 2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0. 6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0. 001). Adverse events were very similar between drug and placebo.

A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia [Completed]
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).

more trials >>

Reports of Suspected Emsam (Selegiline Transdermal) Side Effects

Application Site Erythema (24)Application Site Rash (17)Drug Ineffective (15)Depression (15)Insomnia (14)Application Site Pruritus (13)Application Site Vesicles (8)Headache (7)Drug Effect Decreased (7)Anxiety (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Emsam has an overall score of 7. The effectiveness score is 7.50 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Emsam review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   major chronic depressive disorder
Dosage & duration:   20mg (6mg/24h) taken once daily for the period of one year
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I had become so severly depressed that I was incapable of holding a job. My doctor had tried virtually all classifications of meds on the market but none were able to pull me out of the state I was in. My world had become so dark I felt the sun would never shine again. This med allowed me to function again within my family and within the working world. I stopped crying all the time and was able to concentrate and perform the tasks necessary for employment. I got my life back.
Side effects:   Unlike other antidepressants with numerous side effects, this med had no internal side effects. The only complaint I had with this med was the skin irritation at the application site. This I treated with moisturizers and hydrocortisone creams.
Comments:   I simply applied one patch daily to any part of the "trunk" area of my body. It was not a drug I had to be introduced to slowly or weaned off of. I found that the lowest dose available was effective for me. Each day before my shower the previous days patch was removed so the site area could be cleansed. After my shower the new patch was applied in a different location.

 

Emsam review by 57 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   I don't remember (dosage frequency: appllied patch in the morning) for the period of 2 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   None
Side effects:   I became increasingly agitated and angry. After being on it for 2 months, I tried to commit suicide.
Comments:   I had been taking Effexor, Welbutrin and Ritalin for over three years. The combination worked better then any other cocktail I'd taken. I complaine3d to Doctor that I was feeling lethargic so he switched me to Emsam. After a month he increased the dose. I attempted suicide. Found a new doctor.. Now taking cymbalta and welbutrin. Which seem to be working OK but they ain't no miracle drug.

 

Emsam review by 57 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   I don't remember (dosage frequency: appllied patch in the morning) for the period of 2 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   None
Side effects:   I became increasingly agitated and angry. After being on it for 2 months, I tried to commit suicide.
Comments:   I had been taking Effexor, Welbutrin and Ritalin for over three years. The combination worked better then any other cocktail I'd taken. I complaine3d to Doctor that I was feeling lethargic so he switched me to Emsam. After a month he increased the dose. I attempted suicide. Found a new doctor.. Now taking cymbalta and welbutrin. Which seem to be working OK but they ain't no miracle drug.

See all Emsam reviews / ratings >>

Page last updated: 2017-01-12

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