Eldepryl (Selegiline Hydrochloride) - Summary

ELDEPRYL SUMMARY

ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.

ELDEPRYL is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy.

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NEWS HIGHLIGHTS

Media Articles Related to Eldepryl (Selegiline)

Findings That Should Speed The Development Of Drugs For Parkinson's Disease
Source: Health News from Medical News Today [2009.11.19]
Australian scientists have significantly advanced our understanding of dopamine release from nerve cells, findings that should speed the development of more effective drugs for treating Parkinson's Disease. People with Parkinson's Disease suffer from muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement.

Progression Of Parkinson's Disease May Be Prevented By Widely Used Cholesterol-Lowering Drug
Source: Statins News From Medical News Today [2009.10.31]
Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson's disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson's disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.

Avian Influenza Strain Primes Brain For Parkinson's Disease
Source: Bird Flu / Avian Flu News From Medical News Today [2009.08.11]
At least one strain of the H5N1 avian influenza virus leaves survivors at significantly increased risk for Parkinson's disease and possibly other neurological problems later in life, according to new research from St. Jude Children's Research Hospital.

Parkinson's Disease
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2009.04.28]
Title: Parkinson's Disease
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 4/28/2009

NC State Researchers Advance Understanding Of Stem Cells
Source: Genetics News From Medical News Today [2009.11.19]
Researchers from North Carolina State University have identified a gene that tells embryonic stem cells in the brain when to stop producing nerve cells called neurons. The research is a significant advance in understanding the development of the nervous system, which is essential to addressing conditions such as Parkinson's disease, Alzheimer's disease and other neurological disorders.

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Published Studies Related to Eldepryl (Selegiline)

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.

A review of the literature on the selegiline transdermal system: an effective and well-tolerated monoamine oxidase inhibitor for the treatment of depression. [2008]
Objective: To provide a narrative review of the properties of the selegiline transdermal system (STS) for the treatment of depression and its subtypes.Background: Monoamine oxidase inhibitors (MAOIs) once represented the mainstay of therapy for the treatment of major depressive disorder (MDD)... As a result, treatment at the lowest effective dose of 6 mg/24 hours can be administered without the need for dietary modifications.

Selegiline transdermal system (STS) for HIV-associated cognitive impairment: open-label report of ACTG 5090. [2007.11]
CONCLUSION: Long-term use of selegiline was safe and well tolerated in this HIV cohort of HIV with cognitive impairment. Cognitive improvement may be delayed in neuroprotective trials, suggesting that trials longer than 6 months may be necessary to assess the efficacy of putative neuroprotective agents.

Efficacy of selegiline add on therapy to risperidone in the treatment of the negative symptoms of schizophrenia: a double-blind randomized placebo-controlled study. [2007.10.31]
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. Copyright (c) 2007 John Wiley & Sons, Ltd.

Pharmacokinetics and absolute bioavailability of selegiline following treatment of healthy subjects with the selegiline transdermal system (6 mg/24 h): a comparison with oral selegiline capsules. [2007.10]
The selegiline transdermal system is a monoamine oxidase inhibitor that was recently approved by the US Food and Drug Administration for the treatment of major depressive disorder. The current study was conducted during the selegiline transdermal system development program to characterize the single-dose pharmacokinetics and absolute bioavailability of selegiline administered by the 6-mg/24-h selegiline transdermal system in healthy volunteers...

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Clinical Trials Related to Eldepryl (Selegiline)

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.

Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients [Active, not recruiting]
A decrease in mental function often occurs in patients with HIV. Antiretroviral (ARV) drugs are used to treat this but are not entirely effective. Some other therapy could play a role. The drug selegiline in its pill form is used to treat Parkinson's disease, a serious brain disorder. It is believed this drug might protect the brain and repair some damage. This study will use this drug in a "patch" form, which has not been approved by the Food and Drug Administration (FDA), to see if it helps with decreased mental function in patients with HIV. The purpose of this study is to evaluate the use of selegiline transdermal system (STS) in the treatment of decreased mental function in patients with HIV.

Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease [Recruiting]
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.

Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists [Recruiting]
The purpose of the study is to determine if reducing or eliminating a dopamine agonist causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease symptoms.

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