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Drug Patch for Parkinson Available from Israel(Thursday, 22 June 2006) - Contributed by A. Lieberman - Last Updated () Rotigotine Patch Available from Israel Abraham Lieberman MD Apr 30 2006Rotigotine is a dopamine agonist, a drug similar to the currently available drugs: pramipexole (Mirapex) and ropinirole(Requip). The difference is that rotigotine (called Neupro) is administered by a skin patch. This has the potential ofdelivering the drug continuously: while you are asleep or while you are aware, while you eat, or while you exercise.
Rotigotine has been evaluated in PD people with early PD dose as a dose of 12 to 18 mg per day, without any other antiPD drug. Rotigotine has been evaluated in PD people with advanced PD at a similar dose. In advanced PD, rotigotinehas been combined with levodopa. In advanced PD, the dose of levodopa is reduced as the dose of rotigotine isincreased. There is little available information on the use of rotigotine with mirapex or requip. Rotigotine has been tested in the United States and is awaiting approval by the FDA. It is not known when such approvalwill be forthcoming and when rotigotine will be available by prescription from your doctor. Rotigotine can be obtained through Isrameds, by contacting through Email: sales@isrameds.com Website: http://www.isrameds.com/pages/8/index.htm To obtain the drug you must have a prescription from your own doctor. He or she must understand how rotigotine worksand what it’s role is. The abstracts in this article explain, in part, the role of rotigotine. The drug, because it has not yet been approved in the United States, is not covered by insurance. This article is for your information. It is not an endorsement for the drug. Dr Lieberman does not receive funds fromIsrameds, is not an investor in Isrameds. Drugs Today (Barc). 2006 Jan;42(1):21-8.
Related Articles, Links Rotigotine: a novel dopamine agonist for the transdermal treatment of Parkinson's disease.
Zareba G.
Department of Environmental Medicine, University of Rochester, School of Medicine and Dentistry, Rochester, New York14642, USA. Rotigotine is a D3/D2/D1 dopamine agonist delivered through a silicone-based transdermal patch that is administeredonce daily. Pharmacokinetic data in humans have shown that steady-state plasma levels of rotigotine can be reachedbetween 8 and 12 hours, and a stable drug release is maintained throughout the 24-hour patch application. Results of several clinical trials demonstrated that the rotigotine transdermal system is safe, well tolerated and effectivemonotherapy for patients in the early stages of Parkinson's disease. Rotigotine transdermal application alsodemonstrated the possibility of decreasing levodopa dosage in order to decrease its toxic effects in advancedParkinson's disease. In addition, rotigotine has shown efficacy in the treatment of restless legs syndrome. Clinical studies on rotigotine, thefirst transdermally delivered dopamine agonist, are now in progress, and regulatory approval is expected in the nearfuture. CNS Drugs. 2005;19(11):973-81.
Related Articles, Links Rotigotine: in Parkinson's disease.
Reynolds NA, et alAdis International Limited, Auckland, New Zealand. Rotigotine is a non-ergoline dopamine D3/D2/D1 receptor agonist delivered via a transdermal system and has beenevaluated for the treatment of idiopathic Parkinson's disease. Patients with early Parkinson's disease receiving rotigotine monotherapy experienced significantly greater improvementsin parkinsonian symptoms (as measured by Unified Parkinson's Disease Rating Scale scores) compared to placebo intwo large, well designed clinical trials. Significant beneficial effects versus placebo were observed with the 30 and 40 cm2 rotigotine patches in both trials. Patients with advanced Parkinson's disease receiving rotigotine as adjunctive therapy with levodopa experiencedclinically significant reductions from baseline in 'off' time in two well designed clinical trials. In one trial, a large placebo effect was observed, therefore, there was no significant difference between placebo andactive treatment (20, 40 and 60 cm2) for this primary efficacy variable, However, a recent study found a significant (p < or= 0.003) reduction in 'off' time in rotigotine 40 and 60 cm2 recipients versus that in the placebo group. Rotigotine was generally well tolerated in clinical trials as both monotherapy and when administered with levodopa;adverse events were generally mild or moderate in severity.
http://www.parkinsonresearchfoundation.org - Parkinson Research Foundation Clin Neuropharmacol. 2005 May-Jun;28(3):106-10.
Related Articles, Links Safety, tolerability, and efficacy of continuous transdermal dopaminergic stimulation with rotigotine patch in early-stageidiopathic Parkinson disease.
Guldenpfennig WM, et alLittle Company of Mary Medical Centre, Pretoria, South Africa.
Rotigotine is a new dopamine agonist with transdermal patch formulation for the treatment of Parkinson disease. The aimof this study was to investigate safety and efficacy of rotigotine in patients with early-stage Parkinson disease. In this open-label, dose-escalation, safety and efficacy study, 31 patients in the early stages of idiopathic Parkinsondisease received rotigotine to a maximum of 18.0 mg/day. Of the 29 patients who completed the 28-day treatment phase, 24 were maintained at the maximum dose level. The drugwas well tolerated, and skin reactions were mild. A statistically significant improvement in UPDRS I, II, and III scores wasobserved from baseline to end of treatment for the 29 subjects who completed the trial. Mean improvement (+/- standard deviation) was -2.8 +/- 3.3 on UPDRS II Activities of Daily Living (P = 0.0001)-4.6 +/- 5.3 on UPDRS III Motor part of UPDRS (P < 0.0001). When results were stratified by maximum dose achieved, significant improvements were seen on all subscores forpatients achieving the maximum dose. These data suggest that rotigotine is a safe, well-tolerated, and effectivetreatment for early-stage Parkinson disease.
Arch Neurol. 2003 Dec;60(12):1721-8.
Related Articles, Links A controlled trial of rotigotine monotherapy in early Parkinson's disease.
The Parkinson Study Group.
BACKGROUND: Oral dopamine agonists are effective for treating early Parkinson's disease (PD). Rotigotine is adopamine agonist delivered through a silicone-based transdermal patch that is replaced every 24 hours. OBJECTIVES: To assess the efficacy and safety of rotigotine in patients with PD not receiving dopaminergicmedications. Randomized, double-blind, placebo-controlled study. 242 patients with early PD. Treatment with patches containing either 4.5 mg, 9.0 mg, 13.5 mg or 18.0 mg of rotigotine orplacebo for 11 weeks. The change in the sum of the scores of the activities of daily living and motor components of the Unified Parkinson'sDisease Rating Scale from baseline to the end of treatment. RESULTS: There was a significant dose-related improvement in the motor and activities of daily living UnifiedParkinson's Disease Rating Scale score between baseline and week 11 for the 13.5 mg and 18.0-mg groups comparedwith placeboPlacebo a decrease in 0.3 +/- 7.7Rotigotine 13.5-mg a decrease (improvement) 5.1 +/- 7.0, P =.001Rotigotine 18.0-mg a decrease (improvement) 5.3 +/- 7.0, P<.001). Adverse experiences that occurred more commonly among subjects randomized to active treatment vs placebo includednausea, application site reactions, dizziness, insomnia, somnolence, vomiting, and fatigue. CONCLUSIONS: Rotigotine can be safely administered once daily transdermally and improves parkinsonian signs inpatients with early PD.
Clin Neuropharmacol. 2001 May-Jun;24(3):163-9.
Related Articles, Links Continuous transdermal dopaminergic stimulation in advanced Parkinson's disease.
Metman LV et alNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
The objective of the study was to determine the safety and efficacy of increasing doses of Rotigotine CDS in patientswith advanced Parkinson's disease. The development of motor complications in Parkinson's disease has been linked tointermittent stimulation of dopamine receptors. Continuous, noninvasive, dopaminergic stimulation has not been available to date. Rotigotine CDS is a lipid-soluble D2dopamine agonist in a transdermal delivery system that could fill this void. This inpatient study consisted of a 2-week dose escalation phase followed by a 2-week dose maintenance phase at thehighest dose (80 cm2). Each individual's L-Dopa dose was back-titrated as feasible. The primary outcome measure was L-Dopa dose, and secondary outcome measures included early morning "off"-L-Dopa Unified Parkinson's Disease Rating Scale motor scores by a blinded evaluator and motor fluctuation data obtained http://www.parkinsonresearchfoundation.org - Parkinson Research Foundation from patient diaries ("on" without dyskinesia, "on" with dyskinesia, and "off"). 7 of 10 subjects provided data that could be evaluated. There were two administrative dropouts, and one individual waseliminated from the study because of recrudescence of hallucinations. The median daily L-Dopa dose decreased from 1,400 to 400 mg (p = 0.018) . Unified Parkinson's Disease Rating Scalemotor scores were unchanged. Although diary variables improved in most individuals, only the reduction in "off" timeattained statistical significance. Adverse effects were mild and consisted mainly of dopaminergic side effects and local skin reactions. The data suggestthat Rotigotine CDS is an effective treatment for advanced Parkinson's disease and permits patients to substantiallylower L-Dopa doses without loss of antiparkinsonian efficacy. Full-scale controlled clinical trials are warranted. In addition to potential therapeutic benefits, this drug can be used to testthe hypothesis that continuous dopaminergic stimulation from the initiation of Parkinson's disease therapy will limit thedevelopment of motor complications.
http://www.parkinsonresearchfoundation.org - Parkinson Research Foundation

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