Selegiline orally disintegrating tablet in the treatment of Parkinson's disease

Therapy

Volumn 3, Issue 3, 2006, Pages 349-356

  Clarke, Anthony ^a   Jankovic, Joseph ^b  

^a Amarin Neuroscience Limited   (United Kingdom)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Adjunctive therapy; CNS; Dyskinesia; Monoamine oxidase inhibitors; Orally disintegrating tablet; Parkinson's disease; Selegiline; Zydis fast dissolve drug delivery technology

Indexed keywords

AMPHETAMINE; ANTIDEPRESSANT AGENT; CLONAZEPAM; DOPAMINE RECEPTOR STIMULATING AGENT; DRUG METABOLITE; ENTACAPONE; FAMOTIDINE; LEVODOPA; LORATADINE; METHAMPHETAMINE; MONOAMINE OXIDASE B INHIBITOR; NORSELEGILINE; OLANZAPINE; ONDANSETRON; PETHIDINE; PIROXICAM; PLACEBO; PRAMIPEXOLE; RASAGILINE; RIZATRIPTAN; SELEGILINE; TYRAMINE;

AREA UNDER THE CURVE; ARTICLE; BIOTECHNOLOGY; CLINICAL TRIAL; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG METABOLISM; DRUG RELEASE; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; DYSKINESIA; DYSPEPSIA; HALLUCINATION; HEADACHE; HUMAN; LONG TERM CARE; MONOTHERAPY; MOTOR DYSFUNCTION; MOTOR PERFORMANCE; MOUTH DISEASE; PARKINSON DISEASE; PHARMACODYNAMICS; TABLET DISINTEGRATION;

EID: 33745066865     PISSN: 14750708     EISSN: 1744831X     Source Type: Journal    
DOI: 10.2217/14750708.3.3.349     Document Type: Article

References (52)

1. Shojaei AH. Buccal mucosa as a route for systemic drug delivery: a review. J. Pharm. Pharm. Sci. 1(1), 15-30 (1998).
2. Lavelle EC. Targeted delivery of drugs to the gastrointestinal tract. Crit. Rev. Ther. Drug Carrier Syst. 18(4), 341-386 (2001).
3. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin. Pharmacokinet. 41(9), 661-680 (2002).
4. Zhang Y, Benet LZ. The gut as a barrier to drug absorption: combined role of cytochrome P450 3A and P-glycoprotein. Clin. Pharmacokinet. 40(13), 159-168 (2001).
5. Heyneman CA, Lawless-Liday C, Wall GC. Oral versus topical NSAIDs in rheumatic diseases: a comparison. Drugs 60(3), 555-574 (2000).
6. Lambkin I, Pinilla C. Targeting approaches to oral drug delivery. Expert Opin. Biol. Ther. 2(1), 67-73 (2002).
7. Dmochowski RR, Staskin DR. Advances in drug delivery: improved bioavailability and drug effect. Curr. Urol. Rep. 3(6), 439-444 (2002).
8. Mercadante S, Fulfaro F. Alternatives to oral opioids for cancer pain. Oncology (Williston Park) 13(2), 215-20, 225 (1999).
9. Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J. Pharm. Pharmacol. 5(4), 375-382 (1998).
10. The Parkinson Study Group. Effect of deprenyl on the progression of disability in early Parkinson's disease. N. Engl. J. Med. 321(20), 1364-1371 (1989).
11. Larsen JP, Boas J. The effects of early selegiline therapy on long-term levodopa treatment and parkinsonian disability: an interim analysis of a Norwegian-Danish 5-year study Norwegian-Danish Study Group. Mov. Disord. 12(2), 175-182 (1997).
12. Myllyla VV, Sotaniemi KA. Hakulinen P, Maki-Ikola O, Heinonen EH. Selegiline as the primary treatment of Parkinson's disease - a long-term double-blind study. Acta Neurol. Scand. 95(4). 211-218 (1997).
13. Shoulson I, Oakes D, Fahn S et al. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson's disease: a randomized placebo-controlled extension of the deprenyl and tocopherol anti-oxidative therapy of parkinsonism trial. Ann. Neurol. 51(5), 604-612 (2002).
14. Ives NJ, Stowe RL, Marro J et al. Monoamine oxidase type B inhibitors in early Parkinson's disease: meta-analysis of 17 randomised trials involving 3525 patients. Br. Med. J. 329(7466), 593 (2004).
15. Cedarbaum JM, Toy LH, Green-Parsons A. L-deprenyl (selegiline) added to Sinemet CR in the management of Parkinson's disease patients with motor response fluctuations. Clin. Neuropharmacol. 14(3), 228-234 (1991).
16. Hubble JP, Koller WC, Waters C. Effects of selegiline dosing on motor fluctuations in Parkinson's disease. Clin. Neuropharmacol. 16(1), 83-87 (1993).
17. Sharma SK, Carlson EC, Ebadi M. Neuroprotective actions of Selegiline in inhibiting 1-methy 1, 4-phenyl, pyridinium ion (MPP+)-induced apoptosis in SK-N-SH neurons. J. Neurocytol. 32(4), 329-343 (2003).
18. The Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. N. Engl. J. Med. 328(3), 176-183 (1993).
19. Golbe LI. Long-term efficacy and safety of deprenyl (selegiline) in advanced Parkinson's disease. Neurology. 39(8), 1109-1111 (1989).
20. Ben-Shlomo Y, Churchyard A, Head J et al. Investigation by Parkinson's Disease Research Group of United Kingdom into excess mortality seen with combined levodopa and selegiline treatment in patients with early, mild Parkinson's disease: further results of randomised trial and confidential inquiry. Br. Med. J. 316(7139), 1191-1196 (1998).
21. Olanow CW, Myllyla VV, Sotaniemi KA et al. Effect of selegiline on mortality in patients with Parkinson's disease: a meta-analysis. Neurology 51(3), 825-830 (1998).
22. Marras C, McDermott MP, Rochon PA et al. Survival in Parkinson's disease: thirteen-year follow-up of the DATATOP cohort. Neurology 64(1), 87-93 (2005).
23. Mahmood I. Clinical pharmacokinetics and pharmacodynamics of selegiline. An update. Clin. Pharmacokinet. 33(2), 91-102 (1997).
24. Shin HS. Metabolism of selegiline in humans. Identification, excretion, and stereochemistry of urine metabolites. Drug Metab. Dispos. 25(6), 657-662 (1997).
25. Reams BD, Palmer SM. Sublingual tacrolimus for immunosuppression in lung transplantation: a potentially important therapeutic option in cystic fibrosis. Am. J. Respir. Med. 1(2), 91-98 (2002).
26. Waters CH, Sethi KD, Hauser RA, Molho E, Bertoni JM, and the Zydis Selegiline Study Group. Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: a 3-month, randomized, placebo-controlled study. Mov. Disord. 19(4), 426-432 (2004).
27. Lehoczky O, Udvary J, Pulay T. Freeze dried ondansetron: first observations with the fast dissolving oral anti-emetic Zofran Zydis for the prophylaxis of the cisplatin-induced emesis in gynecological cancer patients. Neoplasma 49(2), 126-128 (2002).
28. Kinon BJ, Hill AL, Liu H, Kollack-Walker S. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia. Int. J. Neuropsychopharmacol. 6(2), 97-102 (2003).
29. Susman J, Klee B. The role of high-potency benzodiazepines in the treatment of panic disorder. Prim. Care Companion J. Clin. Psychiatry 7(1), 5-11 (2005).
30. Gladstone JP, Gawel M. Newer formulations of the triptans: advances in migraine management. Drugs 63(21), 2285-2305 (2003).
31. Marjama-Lyons JM, Koller WC. Parkinson's disease. Update in diagnosis and symptom management. Geriatric. 56(8), 24-30, 33 (2001).
32. Hampton T. Parkinson's disease registry launched. JAMA 293(2), 149 (2005).
33. Schulz JB, Falkenburger BH. Neuronal pathology in Parkinson's disease. Cell Tissue Res. 318(1), 135-147 (2004).
34. Guttman M, Kish SJ, Furukawa Y. Current concepts in the diagnosis and management of Parkinson's disease. CMAJ 168(3), 293-301 (2003).
35. Hamani C, Lozano AM. Physiology and pathophysiology of Parkinson's disease. Ann. N. Y. Acad. Sci. 99115-21 (2003).
36. Braak H, Ghebremedhin E, Rub U, Bratzke H, Del TK. Stages in the development of Parkinson's disease-related pathology. Cell Tissue Res. 318(1), 121-134 (2004).
37. Olanow CW, Agid Y, Mizuno Y et al. Levodopa in the treatment of Parkinson's disease: current controversies. Mov Disord. 19(9), 997-1005 (2004).
38. Jankovic J. Levodopa strengths and weaknesses. Neurology 58(4 Suppl. 1), S19-S32 (2002).
39. Jankovic J. Tardive syndromes and other drug-induced movement disorders. Clin. Neuropharmacol. 18(3), 197-214 (1995).
40. Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov. Disord. 20(2), 224-230 (2005).
41. Maurel F, Lilliu H, Le PC. Social and economic cost of L-Dopa-induced dyskinesias in patients with Parkinson's disease]. Rev. Neurol. (Paris). 157(5), 507-514 (2001).
42. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson's disease and motor fluctuations: the PRESTO study. Arch. Neurol. 62(2), 241-248 (2005).
43. Rascol O, Brooks DJ, Melamed E et al. 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 365(9463), 947-954 (2005).
44. Dewey RB, Jr. Management of motor complications in Parkinson's disease. Neurology 62(6 Suppl. 4), S3-S7 (2004).
45. Hinds NP, Hillier CE, Wiles CM. Possible serotonin syndrome arising from an interaction between nortriptyline and selegiline in a lady with parkinsonism. J. Neurol. 247(10), 811 (2000).
46. Zornberg GL, Bodkin JA, Cohen BM. Severe adverse interaction between pethidine and selegiline. Lancet 337(8735), 246 (1991).
47. Clarke A, Brewer F, Johnson ES et al. A new formulation of selegiline: improved bioavailability and selectivity for MAO-B inhibition. J. Neural Transm. 110(11), 1241-1255 (2003).
48. Clarke A, Johnson ES, Mallard N et al. A new low-dose formulation of selegiline: clinical efficacy, patient preference and selectivity for MAO-B inhibition. J. Neural Transm. 110(11), 1257-1271 (2003).
49. Ondo W. Pooled analysis of two identical Phase 3 studies of a novel selegiline preparation as adjunctive therapy for Parkinson's disease [abstract 239]. Presented at the 2006 World Parkinson Congress. Washington, DC; February 24, 2006.
50. Rinne UK, Larsen JP, Siden A, Worm-Petersen J. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology 51(5), 1309-1314 (1998).
51. Fénelon G, Giménez-Roldán S, Montastruc JL et al. Efficacy and tolerability of entacapone in patients with Parkinson's disease treated with levodopa plus a dopamine agonist and experiencing wearing-off motor fluctuations. A randomized, double-blind, multicentre study. J. Neural Transm. 110(3), 239-251 (2003).
52. Guttman M, and the International Pramipexole-Bromocriptine Study Group. Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease. Neurology 49(4), 1060-1065 (1997).