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

Journal of Clinical Pharmacology

Volumn 53, Issue 5, 2013, Pages 523-531

  Mao, Zhongping ^a   Hsu, Ann ^a   Gupta, Suneel ^a   Modi, Nishit B ^a  

^a Impax Pharmaceuticals   (United States)

Author keywords

IPX066; Levodopa; Parkinson's disease; Pharmacodynamics

Indexed keywords

CARBIDOPA PLUS LEVODOPA; IPX 054; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; DRUG HALF LIFE; DRUG RELEASE; DYSKINESIA; EXTENDED DRUG RELEASE; FEMALE; HUMAN; IMMEDIATE DRUG RELEASE; MALE; MULTICENTER STUDY; OPEN STUDY; PARKINSON DISEASE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME; UNIFIED PARKINSON DISEASE RATING SCALE;

ANTIPARKINSON AGENTS; CARBIDOPA; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DRUG COMBINATIONS; DYSKINESIAS; FEMALE; HUMANS; LEVODOPA; MALE; MODELS, BIOLOGICAL; PARKINSON DISEASE;

EID: 84880152172     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.63     Document Type: Article

References (35)

1. Lees AJ, Hardy J, Revesz T. Parkinson's disease. Lancet. 2009; 373:2055-2066.
2. Martinez-Martin P, Gil-Nagel A, Gracia LM, Gómez JB, Martinez- Sarriés J, Bermejo F. Unified Parkinson's disease rating scale characteristics and structure. The Cooperative Multicentric Group. Mov Disord. 1994;9:76-83. (Pubitemid 24022618)
3. Olanow C, Stern M, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease. Neurology. 2009;72 (suppl 4):S1- S136.
4. Schapira AHV, Emre M, Jenner P, Poewe W. Levodopa in the treatment of Parkinson's disease. Eur J Neurol. 2009;16:982-989.
5. Poewe W, Antonini A, Zijlmans JCM, Burkhard PR, Vingerhoets F. Levodopa in the treatment of Parkinson's disease: an old drug still going strong. Clin Interv Aging. 2010;5:229-238.
6. Cedarbaum JM, Kutt H, McDowell FH. A pharmacokinetic and pharmacodynamic comparison of Sinemet CR (50/200) and standard Sinemet (25/100). Neurology. 1989;39 (Suppl 2):S38-S44.
7. Nyholm D, Askmark H, Gomes-Trolin C, et al. Optimizing levodopa pharmacokinetics: intestinal infusion versus oral sustained-release tablets. Clin Neuropharmacol. 2003;26:156-163. (Pubitemid 36676295)
8. Brooks DJ. Optimizing levodopa therapy for Parkinson's disease with levodopa/carbidopa/entacapone: implications for a clinical and patient perspective. Neuropsychiatr Dis Treat. 2008;4:39-47. (Pubitemid 351460978)
9. Stocchi F, Patsalos PN, Berardelli A, et al. Clinical implications of sustained dopaminergic stimulation. Clin Neuropharmacol. 1994; 17(suppl 2):S7-S13. (Pubitemid 24379404)
10. Stocchi F, Ruggieri S, Monge A, et al. Clinical efficacy of single morning doses of different levodopa formulations. Clin Neuropharmacol. 1994;17 (suppl 3):S16-S20.
11. LeWitt PA. Clinical studies with and pharmacokinetic considerations of sustained-release levodopa. Neurology. 1992;42 (suppl 1): S29-S32.
12. Hauser RA. Levodopa: past, present, and future. Eur Neurol. 2009;62:1-8.
13. Hauser RA, Ellenbogen A, Metman, L, et al. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov Disord. 2011;26:2246-2252.
14. Boraud T, Tison F, Gross C. Quantification of motor slowness in Parkinson's disease: correlations between the tapping test and single joint ballistic movement parameters. Parkinsonism Relat Disord. 1997;3:47-50. (Pubitemid 28090200)
15. Hauser RA, Friedlander J, Zesiewicz T, et al. A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol. 2000;23:75-81. (Pubitemid 30212216)
16. Nelson MV, Berchou RC, LeWitt P, et al. Pharmacokinetic and pharmacodynamic modeling of levodopa plasma concentrations and clinical effects in Parkinson's disease after Sinemet. Clin Neuropharmacol. 1989;12:91-97. (Pubitemid 19088634)
17. LeWitt PA, Nelson MV, Berchou RC, et al. Controlled-release carbidopa/levodopa (Sinemet 50/200 CR4): clinical and pharmacokinetic studies. Neurology 1989;39 (suppl 2):S45-S53.
18. Chan PLS, Nutt JG, Holford NHG. Modeling the short- and longduration responses to exogenous levodopa and to endogenous levodopa production in Parkinson's disease. J Pharmacokinet Pharmacodyn. 2004;31:243-267.
19. Baas H, Zehrden F, Selzer R, Kohnen R, Loetsch J, Harder S. Pharmacokinetic-pharmacodynamic relationship of levodopa with and without tolcapone in patients with Parkinson's disease. Clin Pharmacokinetic. 2001;40:383-393. (Pubitemid 32565598)
20. Contin M, Riva R, Martinelli P, Albani F, Avoni P, Baruzzi A. Levodopa therapy monitoring in patients with Parkinson disease: a kinetic-dynamic approach. Ther Drug Monit. 2001;23:621-629. (Pubitemid 33086489)
21. Triggs EJ, Charles BG, Contin M, et al. Population pharmacokinetics and pharmacodynamics of oral levodopa in parkinsonian patients. Eur J Clin Pharmacol. 1996;51:59-67. (Pubitemid 26300935)
22. Trocóniz IF, Naukkarinen TH, Ruottinen HM, Rinne UK, Gordin A, Karlsson MO. Population pharmacodynamic modeling of levodopa in patients with Parkinson's disease receiving entacapone. Clin Pharmacol Ther. 1998;64:106-116. (Pubitemid 28377336)
23. Mandema JW, Stanski DR. Population pharmacodynamic model for ketorolac analgesia. Clin Pharmacol Ther. 1996;60:619- 635. (Pubitemid 27025909)
24. Nelson MV, Berchou RC, LeWitt PA, Kareti D, Galloway MP. Pharmacodynamic modeling of concentration-effect relationships after controlled-release carbidopa/levodopa (Sinemet CR4) in Parkinson's disease. Neurology. 1990;40:70-74. (Pubitemid 20032896)
25. Adamiak U, Kaldonska M, Klodowska-Duda G, et al. Pharmacokinetic- pharmacodynamic modeling of levodopa in patients with advanced Parkinson disease. Clin Neuropharmacol. 2010;33:135- 141.
26. Harder S, Baas H, Rietbrock S. Concentration-effect relationship of levodopa in patients with Parkinson's disease. Clin Pharmacokinet. 1995;29:243-256.
27. Contin M, Riva R, Martinelli P, Baruzzi A. Kinetic-dynamic relationship of oral levodopa: possible biphasic response after sequential doses in Parkinson's disease. Mov Disord. 1992;7:244- 248.
28. Kumar A, Mann S, Sossi V, et al. [11C]DTBZ-PET correlates of levodopa responses in asymmetric Parkinson's disease. Brain. 2003;126:2648-2655. (Pubitemid 37463084)
29. Contin M, Martinelli P, Scaglione C, et al. The effect of entacapone on levodopa rate of absorption and latency to motor response in patients with Parkinson disease. Clin Neuropharmacol. 2008;31: 267-271.
30. Brodsky MA, Park BS, Nutt JG. Effects of a dopamine agonist on the pharmacodynamics of levodopa in Parkinson disease. Arch Neurol. 2010;67:27-32.
31. Contin M, Riva R, Martinelli P, Cortelli P, Albani F, Baruzzi A. Pharmacodynamic modeling of oral levodopa: clinical application in Parkinson's disease. Neurology. 1993;43:367-371. (Pubitemid 23060272)
32. Chaná P, Kuntsmann C, Reyes-Parada M, Sáez-Briones P. Delayed early morning turn "ON" in response to a single dose of levodopa in advanced Parkinson's disease: pharmacokinetics should be considered. J Neurol Neurosurg Psychiatry. 2004;75: 1782-1783. (Pubitemid 39611489)
33. Frankel JP, Pirtosek Z, Kempster PA, et al. Diurnal differences in the response to oral levodopa. J Neurol Neurosurg Psychiatry. 1990;53:948-950. (Pubitemid 20378895)
34. Nutt JG, Carter JH, Lea ES, Woodward WR. Motor fluctuations during continuous levodopa infusions in patients with Parkinson's disease. Mov Disord. 1997;12:285-292. (Pubitemid 27216124)
35. Nutt JG, Carter JH, Van Houten L, Woodward WR. Short- and longduration responses to levodopa during the first year of levodopa therapy. Ann Neurol. 1997;42:349-355.