An expert opinion on safinamide in Parkinson's disease

Expert Opinion on Investigational Drugs

Volumn 17, Issue 7, 2008, Pages 1115-1125

  Onofrj, Marco ^a   Bonanni, Laura ^a   Thomas, Astrid ^a  

^a UNIVERSITY OF CHIETI   (Italy)

Author keywords

Glutamate; Monoamine oxidase B; Motor fluctuations; Neuroprotection; Parkinson's disease; Safinamide

Indexed keywords

AMANTADINE; AMPHETAMINE; APOMORPHINE; BROMOCRIPTINE; CABERGOLINE; CALCIUM CHANNEL; CARBIDOPA; CATECHOL METHYLTRANSFERASE INHIBITOR; CHOLINERGIC RECEPTOR BLOCKING AGENT; DOPAMINE RECEPTOR BLOCKING AGENT; GLUTAMIC ACID; ISRADIPINE; LEVODOPA; MONOAMINE OXIDASE B INHIBITOR; PERGOLIDE; PIRIBEDIL; PLACEBO; PRAMIPEXOLE; RASAGILINE; ROPINIROLE; SAFINAMIDE; SELEGILINE; SODIUM CHANNEL;

ADD ON THERAPY; ADJUVANT THERAPY; AREA UNDER THE CURVE; ARTICLE; BINDING AFFINITY; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CHEMICAL MODIFICATION; CLINICAL TRIAL; COGNITIVE DEFECT; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENCY; DRUG POTENTIATION; DRUG SAFETY; DRUG SELECTIVITY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG TRANSFORMATION; DYSKINESIA; ENDOCARDITIS; FOOD; FOOD DRUG INTERACTION; GASTROINTESTINAL DISEASE; HUMAN; HYPERTENSION; INCIDENCE; INFECTION; INFESTATION; LEG EDEMA; LIPOPHILICITY; LIVEDO RETICULARIS; LONG TERM CARE; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MEDLINE; MENTAL HEALTH; MONOTHERAPY; MORNING DOSAGE; MOTOR DYSFUNCTION; NEUROLOGIC DISEASE; NEUROPROTECTION; NONHUMAN; OBSESSIVE COMPULSIVE DISORDER; PARKINSON DISEASE; PROTEIN SECRETION; REPEATED DRUG DOSE; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SLEEP DISORDER; SODIUM CURRENT; STRUCTURE ACTIVITY RELATION; STRUCTURE ANALYSIS; SUBCUTANEOUS TISSUE DISORDER; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; XEROSTOMIA;

ALANINE; ANIMALS; BENZYLAMINES; DRUG DESIGN; DRUG TOLERANCE; HUMANS; NEUROPROTECTIVE AGENTS; PARKINSON DISEASE;

EID: 48349109967     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543784.17.7.1115     Document Type: Article

References (62)

1. Rajput AH, Offord KP, Beard CM, Kurland LT. Epidemiology of parkinsonism: incidence, classification, and mortality. Ann Neurol 1984;16:278-82
2. Clarke CRA. Neurological disease. In: Kumar P, Clark M, editors, Clinical medicine. 4th edition. WB Saunders, Edinburgh, UK; 1999. p. 1062-4
3. Verhagen Metman L, Del Dotto P, Blanchet PJ, et al. Blockade of glutamatergic transmission as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Amino Acids 1998;14:75-82
4. Onofrj M, Paci C, Thomas A. Sudden appearance of invalidating dyskinesia-dystonia and off fluctuations after the introduction of levodopa in two dopaminomimetic drug naive patients with stage IV Parkinson's disease. J Neurol Neurosurg Psychiatry 1998;65:605-6
5. Jankovic J. Motor fluctuations and dyskinesias in Parkinson's disease: clinical manifestations. Mov Disord 2005;20(Suppl 11):S11-6
6. Ravina BM, Fagan SC, Hart RG, et al. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology 2003;60:1234-40
7. Stocchi F, Olanow CW, Hunot S, et al. Neuroprotection in Parkinson's disease: clinical trials. Ann Neurol 2003;53:S87-99
8. Jenner P. Oxidative stress in Parkinson's disease. Ann Neurol 2003;53:S26-36
9. Hunot S, Hirsch EC. Neuroinflammatory processes in Parkinson's disease. Ann Neurol 2003;53:S49-58
10. McNaught KS, Olanow CW. Proteolytic stress: a unifying concept for the etiopathogenesis of Parkinson's disease. Ann Neurol 2003;53:S73-84
11. Schapira AH, Gu M, Taanman JW, et al. Mitochondria in the etiology and pathogenesis of Parkinson's disease. Ann Neurol 1998;44:S89-98
12. Mytilineou C, Radcliffe P, Leonardi EK, et al. L-deprenyl protects mesencephalic dopamine neurons from glutamate receptor-mediated toxicity in vitro. J Neurochem 1997;68:33-9
13. Jankovic J. Levodopa strengths and weaknesses. Neurology 2002;58(4 Suppl 1):S19-32
14. Rezak M. Current pharmacotherapeutic treatment options in Parkinson's disease. Dis Mon 2007;53:214-22
15. Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. J Am Med Assoc 2002;287:1653-61
16. Winogrodzka A, Bergmans P, Booij J, et al. [(123)I]beta-CIT SPECT is a useful method for monitoring dopaminergic degeneration in early stage Parkinson's disease. J Neurol Neurosurg Psychiatry 2003;74:294-8
17. Whone AL, Watts RL, Stoessl AJ, et al. Slower progression of Parkinson's disease with ropinirole versus levodopa: the REAL-PET study [REAL-PET Study Group]. Ann Neurol 2003;54:93-101
18. Van Camp G, Flamez A, Cosyns B, et al. Treatment of Parkinson's disease with pergolide and relation to restrictive valvular heart disease. Lancet 2004;363:1179-83
19. Zanettini R, Antonini A, Gatto G, et al. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med 2007;356:39-46
20. Thomas A, Bonanni L, Di Iorio A, et al. End-of-dose deterioration in non-ergolinic dopamine agonist monotherapy of Parkinson's disease. J Neurol 2006;253:1633-9
21. Ulivelli M, Rossi S, Lombardi C, et al. Polysomnographic characterization of pergolide-induced sleep attacks in idiopathic PD. Neurology 2002;58:462-5
22. Kleiner-Fisman G, Fisman DN. Risk factors for the development of pedal edema in patients using pramipexole. Arch Neurol 2007;64:820-4
23. Stocchi F. Pathological gambling in Parkinson's disease. Lancet Neurol 2005;10:590-2
24. Moussa BH, Bakhle Y, Bakhle YS. Monoamine oxidase: isoforms and inhibitors in Parkinsons's disease and depressive illness. Br J Pharmacol 2006;147:S287-96
25. Golbe LI, Lieberman AN, Muenter MD, et al. Deprenyl in the treatment of symptom fluctuations in advanced Parkinson's disease. Clin Neuropharmacol 1988;11:45-55
26. Waters CH, Sethi KD, Hauser RA, et al. Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: a 3-month, randomized, placebo-controlled study. Mov Disord 2004;19:426-32
27. Pahwa R, Factor SA, Lyons KE, et al. Practice parameter: treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2006;66(7):983-95
28. Lew MF, Pahwa R. Leehey M, et al. Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease. Curr Med Res Opin 2007;23:741-50
29. Guay DRP. Rasagiline (TVP-1012): a new selective monoamine oxidase inhibitor for Parkinson's disease. Am J Geriatr Pharmacother 2006;4:330-46
30. Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: the TEMPO Study. Arch Neurol 2002;59:1937-43
31. Rascol O, Brooks DJ, Melamed E, et al. 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;365:947-54. Comment in: Lancet 2005;365:914-6
32. 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
33. Verhagen Metman L, Del Dotto P, Van Den Munckhof P, et al. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology 1998;50:1323-6
34. Metman LV, Del Dotto P, Lepoole K, et al. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch Neurol 1999;56:1383-6
35. Blanchet PJ, Metman LV, Chase TN. Renaissance of amantadine in the treatment of Parkinson's disease. Adv Neurol 2003;91:251-7
36. Del Dotto P, Pavese N, Gambaccini G, et al. Intravenous amantadine improves levadopa-induced dyskinesias: an acute double-blind placebo-controlled study. Mov Disord 2001;16:515-20
37. Ruicka E, Streitova H, Jech R, et al. Amantadine infusion in treatment of motor fluctuations and dyskinesias in Parkinson's disease. J Neural Transm 2000;102:1297-306
38. Thomas A, Iacono D, Luciano AL, et al. Duration of amantadine benefit on dyskinesia of severe Parkinson's disease. J Neurol Neurosurg Psychiatry 2004;75:141-3
39. Moresco RM, Volonte MA, Messa C, et al. New perspectives on neurochemical effects of amantadine in the brain of parkinsonian patients: a PET-[(11)C]raclopride study. J Neural Transm 2002;109:1265-74
40. Perry EK, Kilford L, Lees AJ, et al. Increased Alzheimer pathology in Parkinson's disease related to antimuscarinic drugs. Ann Neurol 2003;54:235-8
41. Fariello RG. Preclinical evaluation of PNU-151774E as a novel anticonvulsant. J Pharmacol Exp Ther 1998;285:397-403
42. Fariello RG. Safinamide. Neurotherapeutics 2007;4:110-6
43. No authors listed. Safinamide: FCE 26743, NW 1015, PNU 151774, PNU 151774E. Drugs R&D 2004;5:355-8
44. Chazot PL. Safinamide (Newron Pharmaceuticals). Curr Opin Investig Drugs 2001;2:809-13
45. Binda C, Hubalek F, Li M, et al. Structure of the human mitochondrial monoamine oxidase B. Neurology 2006;67:S5-7
46. Caccia C, Maj R, Calabresi M, et al. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology 2006;67:S18-23
47. Youdim M, Gross A, Finberg J. Rasagiline [N-propargyl-1R(+)-aminoindan], a selective and potent inhibitor of mitochondrial monoamine oxidase B. Br J P 2001;132:500-6
48. Borbe H, Niebch G, Nickel B. Kinetic evaluation of MAO-B-activity following oral administration of selegiline and desmethyl-selegiline in the rat. J Neural Transm 1990;32(Suppl):131-7
49. Cattaneo C, Caccia C, Marzo A, et al. Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition. Clin Neuro Pharm 2003;26:213-7
50. Binda C, Wang J, Pisani L, et al. Structures of human monoamine oxidase B complexes with selective noncovalent inhibitors: safinamide and coumarin analogs. J Med Chem 2007;50:5848-52
51. Parkinson Study Group. DATATOP: a multicenter controlled clinical trial in early Parkinson's disease. Arch Neurol 1989;46:1052-60
52. Marzo A, Dal Bo L, Ceppi Monti N, et al. Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity. Pharmacol Res 2004;50:77-85
53. Fariello RG, Maj R, Caccia C, et al. Safinamide, a novel potential antiepileptic drug: preclinical and early clinical development. Fifth Eilat Conference on New Antiepileptic Drugs; June 2000. Epilepsy Res 2001;43(1):38
54. Marzo A, Dal Bo L, Crivelli F, et al. Pharmacokinetics, pharmacodynamics and tolerability of safinamide, a new anticonvulsant agent. Fifth Eilat Conference on New Antiepileptic Drugs; June 2000. p. 62
55. Stocchi F, Arnold G, Onofrj M, et al. Safinamide Parkinson's Study Group: improvement of motor function in early Parkinson disease by safinamide. Neurology 2004;24:746-8
56. Stocchi F, Vacca L, Grassini P, et al. Symptom relief in Parkinson disease by safinamide: biochemical and clinical evidence of efficacy beyond MAO-B inhibition. Neurology 2006;67:S24-9
57. Goetz CG, Janko K, Blasucci L, Jaglin JA. Impact of placebo assignment in clinical trials of Parkinson's disease. Mov Disord 2003;18:1146-9
58. Blandini F, Martignoni E, Pacchetti C, et al. Simultaneous determination of L-dopa and 3-O-methyldopa in human platelets and plasma using high performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Sci Appl 1997;700;273-82
59. Samadi P, Gregoire L, Rassoulpour A, et al. Effect of kynurenine 3-hydroxylase inhibition on the dyskinetic and antiparkinsonian responses to levodopa in parkinsonian monkeys. Mov Dis 2005;20:792-802
60. Obeso JA, Rodriguez-Oroz MC, Rodriguez M, et al. Pathophysiology of levodopa-induced dyskinesias in Parkinson's disease: problems with the current model. Ann Neurol 2000;47:S22-32
61. Spieker S, Loschmann PA, Klockgether T. The NMDA antagonist budipine can alleviate levodopa-induced motor fluctuations. Mov Disord 1999;14:517-9
62. Schwarzschild MA, Agnati L, Fuxe K, et al. Targeting adenosine A2A receptors in Parkinson's disease. Trends Neurosci 2006;29:647-54