Transdermal rotigotine: A clinically innovative dopamine-receptor agonist for the management of Parkinson's disease

Pharmacotherapy

Volumn 29, Issue 12, 2009, Pages 1452-1467

  Chen, Jack J ^a,b   Swope, David M ^b   Dashtipour, Khashayar ^b   Lyons, Kelly E ^c  

^a LOMA LINDA UNIVERSITY   (United States)

^b LOMA LINDA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF KANSAS SCHOOL OF MEDICINE   (United States)

Author keywords

Dopamine receptor agonist; DRA; Parkinson's disease; Restless legs syndrome; RLS; Rotigotine; Transdermal administration

Indexed keywords

ADRENERGIC RECEPTOR STIMULATING AGENT; APOMORPHINE; BROMOCRIPTINE; CALCIUM CHANNEL BLOCKING AGENT; CYCLOSPORIN; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DIGOXIN; DOPAMINE RECEPTOR; GLUCOCORTICOID; GLYCOPROTEIN P; LEVODOPA; LISURIDE; PIRIBEDIL; PLACEBO; PRAMIPEXOLE; ROPINIROLE; ROTIGOTINE; SEROTONIN; TACROLIMUS;

ACCIDENT; APPLICATION SITE REACTION; ARTHRALGIA; BACKACHE; CONSTIPATION; CRYOPRESERVATION; CRYSTALLIZATION; DIZZINESS; DOPAMINE RELEASE; DOPAMINERGIC ACTIVITY; DRUG ABSORPTION; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG RELEASE; DRUG SAFETY; DRUG STORAGE; DRUG STRUCTURE; DRUG TOLERABILITY; DYSKINESIA; FATIGUE; HALLUCINATION; HEADACHE; HUMAN; INSOMNIA; MAINTENANCE DRUG DOSE; MONOTHERAPY; NAUSEA; PARKINSON DISEASE; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PHARMACOPHORE; RESTLESS LEGS SYNDROME; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; SOMNOLENCE; STRUCTURE ACTIVITY RELATION; VOMITING;

ADMINISTRATION, CUTANEOUS; ANIMALS; ANTIPARKINSON AGENTS; CLINICAL TRIALS AS TOPIC; DOPAMINE AGONISTS; DRUG INTERACTIONS; HUMANS; PARKINSON DISEASE; RESTLESS LEGS SYNDROME; TETRAHYDRONAPHTHALENES; THIOPHENES;

EID: 73349092737     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.29.12.1452     Document Type: Review

References (75)

1. . Nutt JG, Wooten GF. Clinical practice: diagnosis and initial management of Parkinson's disease. N Engl J Med 2005;353:1021-7.
2. . Tanner CM. Early intervention in Parkinson's disease: epidemiologic considerations. Ann Epidemiol 1996;6:438-41.
3. . Smith Y, Bevan MD, Shink E, Bolam JP. Microcircuitry of the direct and indirect pathways of the basal ganglia. Neuroscience 1998;86:353-87.
4. . Chen J, Nelson M, Swope D. Parkinson's disease. In: DiPiro J, Talbert R, Yee G, eds. Pharmacotherapy: a pathophysiologic approach, 7th ed. New York: McGraw Hill; 2008:977-88.
5. . Fabbrini G, Mouradian MM, Juncos JL, Schlegel J, Mohr E, Chase TN. Motor fluctuations in Parkinson's disease: central pathophysiological mechanisms, part I. Ann Neurol 1988;24: 366-71.
6. . Mouradian MM, Juncos JL, Fabbrini G, Schlegel J, Bartko JJ, Chase TN. Motor fluctuations in Parkinson's disease: central pathophysiological mechanisms, part II. Ann Neurol 1988;24: 372-8.
7. . Melamed E, Hefti F, Wurtman RJ. Nonaminergic striatal neurons convert exogenous L-dopa to dopamine in parkinsonism. Ann Neurol 1980;8:558-63.
8. . Stockwell KA, Virley DJ, Perren M, et al. Continuous delivery of ropinirole reverses motor deficits without dyskinesia induction in MPTP-treated common marmosets. Exp Neurol 2008;211:172-9.
9. . Olanow CW, Obeso JA, Stocchi F. Continuous dopaminereceptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol 2006;5:677-87.
10. . Deleu D, Hanssens Y, Northway MG. Subcutaneous apomorphine: an evidence-based review of its use in Parkinson's disease. Drugs Aging 2004;21:687-709.
11. . Samanta J, Hauser RA. Duodenal levodopa infusion for the treatment of Parkinson's disease. Expert Opin Pharmacother 2007;8:657-64.
12. . Stocchi F, Ruggieri S, Vacca L, Olanow CW. Prospective randomized trial of lisuride infusion versus oral levodopa in patients with Parkinson's disease. Brain 2002;125(pt 9):2058-66.
13. . Biagioni F, Busceti CL, Molinaro G, et al. Dopamine stimulation via infusion in the lateral ventricle. Ann N Y Acad Sci 2006;1074:337-43.
14. . Babita K, Tiwary AK. Transcutaneous delivery of levodopa: enhancement by fatty acid synthesis inhibition. Mol Pharm 2005;2:57-63.
15. . Elias PM, Menon GK. Structural and lipid biochemical correlates of the epidermal permeability barrier. Adv Lipid Res 1991;24:1-26.
16. . Ranade VV. Drug delivery systems: transdermal drug delivery. J Clin Pharmacol 1991;31:401-18.
17. . Priano L, Albani G, Brioschi A, et al. Transdermal apomorphine permeation from microemulsions: a new treatment in Parkinson's disease. Mov Disord 2004;19:937-42.
18. . Degim IT, Acarturk F, Erdogan D, Demirez Lortlar N. Transdermal administration of bromocriptine. Biol Pharm Bull 2003;26:501-5.
19. . Woitalla D, Muller T, Benz S, Horowski R, Przuntek H. Transdermal lisuride delivery in the treatment of Parkinson's disease. J Neural Transm Suppl 2004;68:89-95.
20. . Montastruc JL, Ziegler M, Rascol O, Malbezin M. A randomized, double-blind study of a skin patch of a dopaminergic agonist, piribedil, in Parkinson's disease. Mov Disord 1999;14:336-41.
21. . Luzardo-Alvarez A, Delgado-Charro MB, Blanco-Mendez J. In vivo iontophoretic administration of ropinirole hydrochloride. J Pharm Sci 2003;92:2441-8.
22. . UCB Pharma Inc. UCB to implement full cold-chain for Neupro, June 4, 2008. Available from http://www.ucb.com/news/3463.asp. Accessed April 8, 2009.
23. . Chaudhuri KR. Crystallisation within transdermal rotigotine patch: is there cause for concern? Expert Opin Drug Deliv 2008;5:1169-71.
24. . Van Oene JC, De Vries JB, Dijkstra D, Renkema RJ, Tepper PG, Horn AS. In vivo dopamine autoreceptor selectivity appears to be critically dependent upon the aromatic hydroxyl position in a series of N,N-disubstituted 2-aminotetralins. Eur J Pharmacol 1984;102:101-15.
25. 2 dopamine receptor agonist. Pharm Weekbl Sci 1985;7:208-11.
26. 2 dopamine receptor agonist in in vitro and in vivo models. Eur J Pharmacol 1988;147:249-58.
27. . den Daas I, Tepper PG, Horn AS. Improvement of the oral bioavailability of the selective dopamine agonist N-0437 in rats: the in vitro and in vivo activity of eight ester prodrugs. Naunyn Schmiedebergs Arch Pharmacol 1990;341:186-91.
28. 2 receptor agonist, is efficacious in rat and monkey models of Parkinson's disease. Mov Disord 1994;9:147-54.
29. . Mucke HA. Rotigotine Schwarz Pharma. IDrugs 2003;6:894-9.
30. . Millan MJ, Maiofiss L, Cussac D, Audinot V, Boutin JA, Newman-Tancredi A. Differential actions of antiparkinson agents at multiple classes of monoaminergic receptor. I. A multivariate analysis of the binding profiles of 14 drugs at 21 native and cloned human receptor subtypes. J Pharmacol Exp Ther 2002;303:791-804.
31. . Scheller D, Ullmer C, Berkels R, Gwarek M, Lubbert H. The in vitro receptor profile of rotigotine: a new agent for the treatment of Parkinson's disease. Naunyn Schmiedebergs Arch Pharmacol 2009;379:73-86.
32. . Kehr J, Hu XJ, Goiny M, Scheller DK. Continuous delivery of rotigotine decreases extracellular dopamine suggesting continuous receptor stimulation. J Neural Transm 2007;114:1027-31.
33. 2 agonist N-0923 in freely moving rats. Pharmazie 1992;47:613-15.
34. . Guldenpfennig WM, Poole KH, Sommerville KW, Boroojerdi B. Safety, tolerability, and efficacy of continuous transdermal dopaminergic stimulation with rotigotine patch in early-stage idiopathic Parkinson disease. Clin Neuropharmacol 2005;28:106-10.
35. . Babic T, Boothmann B, Polivka J, et al. Rotigotine transdermal patch enables rapid titration to effective doses in advancedstage idiopathic Parkinson disease: subanalysis of a parallel group, open-label, dose-escalation study. Clin Neuropharmacol 2006;29:238-42.
36. 14C]rotigotine by a patch formulation: a mass balance trial. Clin Pharmacokinet 2007;46:851-7.
37. . Elshoff J, Cawello W, Braun M, Horstmann R. Stable rotigotine plasma concentrations over 24 hours in patients with earlystage Parkinson's disease after once-daily transdermal administration. Presented at the annual meeting of the American Academy of Neurology, San Diego, CA, April 1-8, 2006.
38. . Braun M, Cawello W, Poole K, Horstmann R. Steady-state pharmacokinetics of rotigotine in patients with early-stage Parkinson's disease. Presented at the European Federation of Neurological Sciences, Athens, Greece, September 17-20, 2005.
39. . Cawello W, Braun M, Horstmann R. Pharmacokinetics of transdermal rotigotine in subjects with impaired renal function. Presented at the 34th annual meeting of the American College of Clinical Pharmacology, Rockville, MD, September 11-13, 2005.
40. . Schwarz Pharma L. Neupro (rotigotine) package insert. Mequon, WI; 2007.
41. . Hansen K, Braun M, Horstmann R. Low drug-drug interaction potential of rotigotine. Presented at the 34th annual meeting of the American College of Clinical Pharmacology, Rockville, MD, September 11-13, 2005.
42. . Metman LV, Gillespie M, Farmer C, et al. Continuous transdermal dopaminergic stimulation in advanced Parkinson's disease. Clin Neuropharmacol 2001;24:163-9.
43. . Parkinson Study Group. A controlled trial of rotigotine monotherapy in early Parkinson's disease. Arch Neurol 2003;60:1721-8.
44. . Watts RL, Jankovic J, Waters C, Rajput A, Boroojerdi B, Rao J. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007;68:272-6.
45. . Giladi N, Boroojerdi B, Korczyn AD, Burn DJ, Clarke CE, Schapira AH. Rotigotine transdermal patch in early Parkinson's disease: a randomized, double-blind, controlled study versus placebo and ropinirole. Mov Disord 2007;22:2398-404.
46. . Bianchine J, Poole K, for the SP506 Study Group. Efficacy and dose response of the novel transdermally applied dopamine agonist rotigotine CDS in early Parkinson's disease. Presented at the 54th annual meeting of the American Academy of Neurology, Denver, CO, April 13-20, 2002.
47. . LeWitt P, Lyons KE, Pahwa R, et al. Safety and tolerability of rotigotine in advanced-stage Parkinson's disease. Presented at the annual meeting of the American Neurological Association, Salt Lake City, UT, September 21-24, 2008.
48. . Jankovic J, Watts RL, Martin W, Boroojerdi B. Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease. Arch Neurol 2007;64:676-82.
49. . Adler CH, Sethi KD, Hauser RA, et al, for the Ropinirole Study Group. Ropinirole for the treatment of early Parkinson's disease. Neurology 1997;49:393-9.
50. . Korczyn AD, Brooks DJ, Brunt ER, Poewe WH, Rascol O, Stocchi F, for the 053 Study Group. Ropinirole versus bromocriptine in the treatment of early Parkinson's disease: a 6-month interim report of a 3-year study. Mov Disord 1998; 13:46-51.
51. . Rascol O, Brooks DJ, Brunt ER, Korczyn AD, Poewe WH, Stocchi F, for the 056 Study Group. Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. Mov Disord 1998;13:39-45.
52. . Quinn N, for the SP511 Investigators. Rotigotine transdermal delivery system (TDS) (SPM 962): a multicenter, double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of rotigotine TDS in patients with advanced Parkinson's disease [abstract]. Parkinsonism Relat Disord 2001;7(suppl 1):S66.
53. . Poewe WH, Rascol O, Quinn N, et al. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol 2007;6:513-20.
54. . LeWitt PA, Lyons KE, Pahwa R. Advanced Parkinson disease treated with rotigotine transdermal system: PREFER study. Neurology 2007;68:1262-7.
55. . Dank N. A proof of concept trial to assess the tolerability, safety, and efficacy of rotigotine nasal spray for the acute treatment of "off" symptoms in subjects with advanced-stage, idiopathic Parkinson disease. ClinicalTrials.gov. March 7, 2008. Available from http://www. clinicaltrials.gov/ct2/show/NCT00296192?term=r otigotine&rank=27. AccessedMay 11, 2009.
56. . Giladi N, Sommerville KW, Researchers S. Rotigotine transdermal patch for better control of early morning motor impairment and sleep disturbances in patients with Parkinson's disease. Presented at the 132nd annual meeting of the American Neurological Association, Washington, DC, October 7-10, 2007.
57. . UCB Pharma Inc. Phase 3B, multicenter, multinational, doubleblind, placebo-controlled, 2-arm trial to evaluate the effect of the 24-hour transdermal delivery of rotigotine on the control of early morning motor function, sleep quality, nocturnal symptoms, and non-motor symptoms in subjects with idiopathic parkinson's disease. March 18, 2009. Available from http://www.clinicaltrials.gov/ct2/show/NCT00474058?term=r otigotine&rank= 13&flds=Xabj. Accessed May 11, 2009.
58. . Korczyn AD, Reichmann H, Boroojerdi B, Hack HJ. Rotigotine transdermal system for perioperative administration. J Neural Transm 2007;114:219-21.
59. . Schwarz Pharma L. Data on file. Mequon, WI; 2007.
60. . Stamey W, Jankovic J. Impulse control disorders and pathological gambling in patients with Parkinson disease. Neurologist 2008;14:89-99.
61. . Giladi N, Weitzman N, Schreiber S, Shabtai H, Peretz C. New onset heightened interest or drive for gambling, shopping, eating or sexual activity in patients with Parkinson's disease: the role of dopamine agonist treatment and age at motor symptoms onset. J Psychopharmacol 2007;21:501-6.
62. . Kulkarni AS, Balkrishnan R, Anderson RT, Edin HM, Kirsch J, Stacy MA. Medication adherence and associated outcomes in medicare health maintenance organization-enrolled older adults with Parkinson's disease. Mov Disord 2008;23:359-65.
63. . LeWitt PA, Boroojerdi B, MacMahon D, Patton J, Jankovic J. Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease. Clin Neuropharmacol 2007;30:256-65.
64. . Chen J. Optimizing use of a dopamine agonist in Parkinson's disease. Pharmacy Times 2007;73:111-21.
65. . Stiasny-Kolster K, Kohnen R, Schollmayer E, Moller JC, Oertel WH. Patch application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome: a double-blind, placebo-controlled pilot study. Mov Disord 2004;19:1432-8.
66. . Oertel WH, Benes H, Garcia-Borreguero D, et al. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dosefinding trial in Europe. Sleep Med 2008;9:228-39.
67. . Garcia-Borreguero D, Poewe W, Hoegl B, et al. Long-term safety and efficacy of rotigotine in idiopathic RLS: 3-year results from a multinational open-label trial. Presented at the 12th congress of the European Federation of Neurological Societies, Madrid, Spain, August 23-26, 2008.
68. . Trenkwalder C, Benes H, Poewe W, et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2008;7:595-604.
69. . Hening W, Allen R, Becker P, et al. Rotigotine 24 h transdermal patch is effective in the treatment of idiopathic RLS: results of a 6-month, multicenter, double-blind, placebo-controlled U.S. trial. Presented at the 12th congress of the European Federation of Neurological Societies, Madrid, Spain, August 23-26, 2008.
70. . Oertel WH, Benes H, Garcia-Borreguero D, et al. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med 2008;9:865-73.
71. . Garcia-Borreguero D, Ferini-Strambi L, Kohnen R. Augmentation in the therapy of the restless legs syndrome with transdermal rotigotine: a retrospective systematic analysis of two large double-blind 6-month trials. Presented at the 12th congress of the European Federation of Neurological Societies, Madrid, Spain, August 23-26, 2008.
72. . UCB Pharma Inc. A randomized, double-blind, placebo-controlled, parallel-group proof-of-concept trial to assess the efficacy, safety and tolerability of ascending doses of rotigotine nasal spray for the acute treatment of RLS symptoms in subjects with idiopathic restless legs syndrome. ClinicalTrials.gov. March 7, 2008. Available from http://www.clinicaltrials.gov/ ct2/show/NCT00389831?term=NCT00 389831&rank=1. AccessedMay 11, 2009.
73. . Korchounov A, Kessler KR, Yakhno NN, Damulin IV, Schipper HI. Determinants of autonomic dysfunction in idiopathic Parkinson's disease. J Neurol 2005;252:1530-6.
74. . Christie J. The use of transdermal rotigotine in a patient with advanced Parkinson's disease and dysphagia. Palliat Med 2007;21:163-4.
75. . Cramer MP, Saks SR. Translating safety, efficacy and compliance into economic value for controlled release dosage forms. Pharmacoeconomics 1994;5:482-504.