Novel levodopa formulations in the treatment of Parkinson's disease

Expert Review of Neurotherapeutics

Volumn 14, Issue 2, 2014, Pages 143-149

  Pilleri, Manuela ^a   Antonini, Angelo ^a  

^a Fondazione Ospedale San Camillo IRCCS   (Italy)

Author keywords

COMT; duodenal infusion; dyskinesia; IPX066; levodopa; MAO B inhibitor; motor complications; Parkinson's disease; pharmacokinetic; wearing off

Indexed keywords

ALCOHOL; AMINE OXIDASE (FLAVIN CONTAINING); APOMORPHINE; BENSERAZIDE; BENSERAZIDE PLUS LEVODOPA; CALCIUM CHLORIDE; CARBIDOPA; CARBIDOPA PLUS LEVODOPA; CATECHOL METHYLTRANSFERASE; CERULENIN; DOPAMINE; DOPAMINE RECEPTOR; ENTACAPONE; IPX 750; LEVODOPA; LEVODOPA METHYL ESTER; NEBICAPONE; PROPYLENE GLYCOL; RASAGILINE; TOLCAPONE; UNCLASSIFIED DRUG;

AREA UNDER THE CURVE; CLINICAL TRIAL (TOPIC); CONTROLLED RELEASE FORMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DYSKINESIA; GOLD STANDARD; HUMAN; MEDICATION COMPLIANCE; MOTOR DYSFUNCTION; NONHUMAN; PARKINSON DISEASE; REVIEW; STOMACH EMPTYING; STRIATONIGRAL DEGENERATION; TREATMENT OUTCOME;

ANTIPARKINSON AGENTS; CHEMISTRY, PHARMACEUTICAL; DRUG ADMINISTRATION ROUTES; DRUG DELIVERY SYSTEMS; HUMANS; LEVODOPA; PARKINSON DISEASE;

EID: 84893053751     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.2014.877840     Document Type: Review

References (70)

1. Jellinger KA. Recent developments in the pathology of Parkinson's disease. J Neural Transm Suppl 2002(62):347-76
2. Obeso JA, Rodríguez-Oroz MC, Benitez-Temino B, et al. Functional organization of the basal ganglia: Therapeutic implications for Parkinson's disease. Mov Disord 2008;23(Suppl 3):S548-59
3. Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson's disease (2001): Treatment guidelines. Neurology 2001;56: S1-S88
4. Parkinson Study Group. Pramipexole vs. levodopa as initial treatment for Parkinson disease: A randomized controlled trial. JAMA 2000;284:1931-8
5. Holloway RG, Shoulson I, Fahn S, et al. Pramipexole vs levodopa as initial treatment for Parkinson disease: A 4-year randomized controlled trial. Arch Neurol 2004;61(7): 1044-53
6. Rascol O, Brooks DJ, Korczyn AD, et al. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. 056 Study Group. N Engl J Med 2000;342(20):1484-91
7. Rinne UK, Bracco F, Chouza C, et al. Early treatment of Parkinson's disease with cabergoline delays the onset of motor complications. Results of a double-blind levodopa controlled trial. The PKDS009 Study Group. Drugs 1998;55(Suppl 1):23-30
8. Oertel WH, Wolters E, Sampaio C, et al. Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study. Mov Disord 2005; 21(3):343-53
9. Parkinson Study Group. Long-Term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol 2009;66(5): 563-70
10. Lees AJ, Katzenschlager R, Head J, Ben-Shlomo Y. Ten-year follow-up of three different initial treatments in de-novo PD: A randomized trial. Neurology 2001;57(9): 1687-94
11. Hauser RA, Rascol O, Korczyn AD, et al. Ten-year follow-up of Parkinson's disease patients randomized to initial therapy with ropinirole or levodopa. Mov Disord 2007; 22(16):2409-17
12. Rascol O, Korczyn A, De Deyn PP, Lang A. Incidence of dyskinesias in a 10-year naturalistic follow-up of patients with early Parkinson's disease (PD) initially receiving ropinirole compared with L-dopa. Mov Disord 2005; 20(Suppl 10):S63
13. Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord 2001;16: 448-58
14. Chase TN, Baronti F, Fabbrini G, et al. Rationale for continuous dopaminomimetic therapy of Parkinson's disease. Neurology 1989;39(11 Suppl 2):7-10
15. Khor SP, Hsu A. The pharmacokinetics and pharmacodynamics of levodopa in the treatment of Parkinson's disease. Curr Clin Pharmacol 2007;2(3):234-43
16. Nutt JG. Pharmacokinetics and pharmacodynamics of levodopa. Mov Disord 2008;23(Suppl 3):S580-4
17. Hardie RJ, Lees AJ, Stern GM. Pharmacokinetics of levodopa and motor fluctuations. Adv Neurol 1987;45:487-92
18. Poewe W, Wenning G. Levodopa in Parkinson's disease: Mechanisms of action and pathophysiology of late failure. In: Jankovic J, Tolosa E, Parkinson's disease and movement disorders. 4th edition Lippincott Williams and Wilkins; Philadelphia, PA, USAs: 2002
19. Birkmayer W, Danielcyk W, Neumayer E, Riederer P. L-Dopa level in plasma, primary condition for the kinetic effect. J Neural Transm 1973;34(2):133-43
20. Stocchi F, Vacca L, Ruggieri S, Olanow CW. Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: A clinical and pharmacokinetic study. Arch Neurol 2005; 62(6):905-10
21. Contin M, Riva R, Albani F, Baruzzi A. Pharmacokinetic optimisation in the treatment of Parkinson's disease. Clin Pharmacokinet 1996;30(6):463-81
22. Grandas F, Galiano ML, Tabernero C. Risk factors for levodopa induced dyskinesias in Parkinson's disease. J Neurol 1999;246: 1127-33
23. Jenner P. Pathophysiology and biochemistry of dyskinesia: Clues for the development of non-dopaminergic treatments. J Neurol 2000;247(Suppl 2):II43-50
24. Calandrella D, Antonini A. Pulsatile or continuous dopaminomimetic strategies in Parkinson's disease. Parkinsonism Relat Disord 2012;18(Suppl 1):S120-2
25. Olanow W, Schapira AH, Rascol O. Continuous dopamine-receptor stimulation in early Parkinson's disease. Trend Neurosci 2000;23(10 Suppl):S117-26
26. Jenner P, McCreary AC, Scheller DK. Continuous drug delivery in early- and late-stage Parkinson's disease as a strategy for avoiding dyskinesia induction and expression. J Neural Transm 2011;118(12): 1691-702
27. Antonini A, Chaudhuri KR, Martinez-Martin P, Odin P. Oral and infusion levodopa-based strategies for managing motor complications in patients with Parkinson's disease. CNS Drugs 2010; 24(2):119-29
28. Yeh KC, August TF, Bush DF, et al. Pharmacokinetics and bioavailability of Sinemet CR: A summary of human studies. Neurology 1989;39(11 Suppl 2):25-38
29. LeWitt PA, Nelson MV, Berchou RC, et al. Controlled-release carbidopa/levodopa (Sinemet 50/200 CR4): Clinical and pharmacokinetic studies. Neurology 1989; 39(11 Suppl 2):45-53
30. Erni W, Held K. The hydrodynamically balanced system: A novel principle of controlled drug release. Eur Neurol 1987; 27(Suppl 1):21-7
31. Marion MH, Stocchi F, Malcolm SL, et al. Single-dose studies of a slow-release preparation of levodopa and benserazide (Madopar HBS) in Parkinson's disease. Eur Neurol 1987;27(Suppl 1):54-8
32. Stocchi F, Fabbri L, Vecsei L, et al. Clinical efficacy of a single afternoon dose of effervescent levodopa-carbidopa preparation (CHF 1512) in fluctuating Parkinson disease. Clin Neuropharmacol 2007;30(1): 18-24
33. Stocchi F, Zappia M, Dall Armi V, Melevodopa Plus Carbidopa Study Group. Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease. Mov Disord 2010;25(12):1881-7
34. Nutt JG, Woodward WR, Beckner RM, et al. Effect of peripheral catechol-Omethyltransferase inhibition on the pharmacokinetics and pharmacodynamics of levodopa in parkinsonian patients. Neurology 1994;44(5):913-19
35. Kaakkola S. Clinical pharmacology, therapeutic use and potential of COMT inhibitors in Parkinson's disease. Drugs 2000;29:1233-50
36. Schrag A. Entacapone in the treatment of Parkinson's disease. Lancet Neurol 2005;4: 366-70
37. Dingemanse J, Jorga KM, Zurcher G, et al. Pharmacokinetic-pharmacodynamic interaction between the COMT inhibitor tolcapone and single-dose levodopa. Br J Clin Pharmacol 1995;40:253-62
38. Napolitano A, Del Dotto P, Petrozzi L, et al. Pharmacokinetics and pharmacodynamics of l-dopa after acute and 6-week tolcapone administration in patients with Parkinson's disease. Clin Neuropharmacol 1999;22:24-9
39. Limousin P, Pollak P, Pfefen JP, et al. Acute administration of levodopa-beserazide and tolcapone, a COMT inhibitor, in Parkinson's disease. Clin Neuropharmacol 1995;28:358-265
40. Factor SA, Molho ES, Feustel PJ, et al. Long-Term comparative experience with tolcapone and entacapone in advanced Parkinson's disease. Clin Neuropharmacol 2001;24:295-9
41. Szelenyi I, editor. Inhibitors of monoamine oxidase B. Pharmacology and clinical use in neurodegenerative disorders. Birkha?user Verlag, Basel, Switzerland; 1993
42. Youdim MB, Riederer PF. A review of the mechanisms and role of monoamine oxidase inhibitors in Parkinson's disease. Neurology 2004;63:S32-5
43. Parkinson Study Group. a controlled trial of rasagiline in early Parkinson disease: The TEMPO Study. Arch Neurol 2002;59: 1937-43
44. Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-Treated patients with Parkinson disease and motor fluctuations: The PRESTO study. Arch Neurol 2005;62: 241-8
45. Rascol O, Brooks DJ, Melamed E, LARGO study group. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): A randomised, double-blind, parallel-group trial. Lancet 2005;365(9463):947-54
46. Nyholm D, Nilsson Remahl AI, Dizdar N, et al. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology 2005;64(2):216-23
47. Mancini F, Comi C, Oggioni GD, et al. Prevalence and features of peripheral neuropathy in Parkinson's disease patients under different therapeutic regimens. Parkinsonism Relat Disord 2013. [Epub ahead of print]
48. Colzi A, Turner K, Lees AJ. Continuous subcutaneous waking day apomorphine in the long term treatment of levodopa induced interdose dyskinesias in Parkinson's disease. J Neurol Neurosurg Psychiatry 1998;64(5):573-6
49. Antonini A, Isaias IU, Rodolfi G, et al. A 5-year prospective assessment of advanced Parkinson disease patients treated with subcutaneous apomorphine infusion or deep brain stimulation. J Neurol 2011;258(4): 579-85
50. Manca D, Cossu G, Murgia D, et al. Reversible encephalopathy and axonal neuropathy in Parkinson's disease during duodopa therapy. Mov Disord 2009;24(15): 2293-4
51. García Ruiz PJ, Sesar Ignacio A, Ares Pensado B, et al. Efficacy of long-Term continuous subcutaneous apomorphine infusion in advanced Parkinson's disease with motor fluctuations: A multicenter study. Mov Disord 2008; 23(8):1130-6
52. Hardie RJ, Malcolm SL, Lees AJ, et al. The pharmacokinetics of intravenous and oral levodopa in patients with Parkinson's disease who exhibit on-off fluctuations. Br J Clin Pharmacol 1986;22(4):429-36
53. Juncos JL, Mouradian MM, Fabbrini G, et al. Levodopa methyl ester treatment of Parkinson's disease. Neurology 1987;37(7): 1242-5
54. Manson AJ, Hanagasi H, Turner K, et al. Intravenous apomorphine therapy in Parkinson's disease: Clinical and pharmacokinetic observations. Brain 2001; 124(Pt 2):331-40
55. Mao Z, Hsu A, Gupta S, Modi NB. Population Pharmacodynamics of IPX066: An Oral Extended-Release Capsule Formulation of Carbidopa-Levodopa, and Immediate-Release Carbidopa-Levodopa in Patients With Advanced Parkinson's Disease. J Clin Pharmacol 2013;53(5):523
56. Hauser RA, Ellenbogen AL, Metman LV, et al. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord 2011;26(12):2246-52
57. Hauser RA, Hsu A, Kell S, IPX066 ADVANCE-PD investigators. Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: A phase 3 randomised, double-blind trial. Lancet Neurol 2013;12(4):346-56
58. Almeida L, Soares-da-Silva P. Pharmacokinetic and pharmacodynamic profiles of BIA-3-202, a novel catechol-O-methyltransferase (COMT) inhibitor, during multiple-dose administration to healthy subjects. J Clin Pharmacol 2003;23:1350-2360
59. Ferreira JJ, Rascol O, Poewe W, BIA-3202-202 Study Investigators. A double-blind, randomized, placebo and active-controlled study of nebicapone for the treatment of motor fluctuations in Parkinson's disease. CNS Neurosci Ther 2010;16(6):337-47
60. Jiang C, Wan X, Jankovic J, et al. Dopaminergic properties and experimental anti-parkinsonian effects of IPX750 in rodent models of Parkinson disease. Clin Neuropharmacol 2004;27(2):63-73
61. Yang X, Yuan W, Ren T, et al. Levodopa/ benserazide-loaded biodegradable microspheres reduce dyskinesia in rats. Neuroreport 2010;21(12):837-40
62. Zhou CQ, Li SS, Chen ZM, et al. Rotigotine transdermal patch in Parkinson's disease: A systematic review and meta-Analysis. PLoS ONE 2013;8(7):e69738
63. Babita K, Tiwary AK. Transcutaneous delivery of levodopa: Enhancement by fatty acid synthesis inhibition. Mol Pharm 2005; 2(1):57-63
64. Koller W, Stacy M. Other formulations and future considerations for apomorphine for subcutaneous injection therapy. Neurology 2004;62(6 Suppl 4):S22-4
65. Chun IK, Lee YH, Lee KE, Gwak HS. Design and evaluation of levodopa methyl ester intranasal delivery systems. J Parkinsons Dis 2011;1(1):101-7
66. Grosset D, Antonini A, Canesi M, et al. Adherence to antiparkinson medication in a multicenter European study. Mov Disord 2009;24(6):826-32
67. ClinicalTrials.gov. Available from: Www. clinicaltrials.gov-PX066-B09-06
68. Kelley BJ, Duker AP, Chiu P Dopamine agonists and pathologic behaviors. Parkinsons Dis 2012;2012:603631
69. Olanow CW, Kieburtz K, Rascol O, Stalevo reduction in dyskinesia evaluation in Parkinson's disease (STRIDE-PD) investigators. Factors predictive of the development of Levodopa-induced dyskinesia and wearing-off in Parkinson's disease. Mov Disord 2013;28(8):1064-71
70. Dupont E, Andersen A, Boas J, et al. Sustained-release Madopar HBS compared with standard Madopar in the long-Term treatment of de novo parkinsonian patients. Acta Neurol Scand 1996;93(1):14-20