Current status of safinamide for the drug portfolio of Parkinson’s disease therapy

References

• de Rijk MC, Launer LJ, Berger K et al. Prevalence of Parkinson’s disease in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology 54(11 Suppl. 5), S21-S23 (2000).
   PubMed Web of Science ®Google Scholar
• Rajput AH, Birdi S. Epidemiology of Parkinson’s disease. Parkinsonism. Relat. Disord. 3(4), 175–186 (1997).
   PubMedGoogle Scholar
• Müller T. Dopaminergic substitution in Parkinson’s disease. Expert. Opin. Pharmacother. 3(10), 1393–1403 (2002).
   PubMedGoogle Scholar
• Przuntek H, Müller T, Riederer P. Diagnostic staging of Parkinson’s disease: conceptual aspects. J. Neural. Transm. 111(2), 201–216 (2004).
   PubMed Web of Science ®Google Scholar
• Rezak M. Current pharmacotherapeutic treatment options in Parkinson’s disease. Dis. Mon. 53(4), 214–222 (2007).
   PubMedGoogle Scholar
• Müller T, Erdmann C, Muhlack S, Bremen D, Przuntek H, Woitalla D. Inhibition of catechol-O-methyltransferase contributes to more stable levodopa plasma levels. Mov. Disord. 21(3), 332–336 (2006).
   PubMed Web of Science ®Google Scholar
• Müller T, Russ H. Levodopa, motor fluctuations and dyskinesia in Parkinson’s disease. Expert Opin. Pharmacother. 7(13), 1715–1730 (2006).
   PubMed Web of Science ®Google Scholar
• Metman LV, Del Dotto P, LePoole K, Konitsiotis S, Fang J, Chase TN. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch. Neurol. 56(11), 1383–1386 (1999).
   PubMedGoogle Scholar
• Müller T, Kuhn W, Schulte T, Przuntek H. Intravenous amantadine sulphate application improves the performance of complex but not simple motor tasks in patients with Parkinson’s disease. Neurosci. Lett. 339(1), 25–28 (2003).
   PubMed Web of Science ®Google Scholar
• Perry EK, Kilford L, Lees AJ, Burn DJ, Perry RH. Increased Alzheimer pathology in Parkinson’s disease related to antimuscarinic drugs. Ann. Neurol. 54(2), 235–238 (2003).
   PubMed Web of Science ®Google Scholar
• Goetz CG, Damier P, Hicking C et al. Sarizotan as a treatment for dyskinesias in Parkinson’s disease: a double-blind placebo-controlled trial. Mov. Disord. 22(2), 179–186 (2007).
   PubMed Web of Science ®Google Scholar
• Gregoire L, Samadi P, Graham J, Bedard PJ, Bartoszyk GD, Di PT. Low doses of sarizotan reduce dyskinesias and maintain antiparkinsonian efficacy of L-Dopa in parkinsonian monkeys. Parkinsonism Relat. Disord. 15(6), 445–452 (2009).
   PubMed Web of Science ®Google Scholar
• Müller T, Hoffmann JA, Dimpfel W, Oehlwein C. Switch from selegiline to rasagiline is beneficial in patients with Parkinson’s disease. J. Neural. Transm. 120(5), 761–765 (2013).
   PubMed Web of Science ®Google Scholar
• Ouattara B, Gregoire L, Morissette M et al. Metabotropic glutamate receptor type 5 in levodopa-induced motor complications. Neurobiol. Aging 32(7), 1286–1295 (2011).
   PubMed Web of Science ®Google Scholar
• Verhagen ML, Del Dotto P, van den MP, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson’s disease. Neurology 50(5), 1323–1326 (1998).
   PubMed Web of Science ®Google Scholar
• Müller T. Drug therapy in patients with Parkinson’s disease. Transl. Neurodegener. 1(1), 1–10 (2012).
   PubMedGoogle Scholar
• Onofrj M, Bonanni L, Thomas A. An expert opinion on safinamide in Parkinson’s disease. Expert Opin. Investig. Drugs 17(7), 1115–1125 (2008).
   PubMed Web of Science ®Google Scholar
• Riederer P, Lachenmayer L, Laux G. Clinical applications of MAO-inhibitors. Curr. Med. Chem. 11(15), 2033–2043 (2004).
   PubMed Web of Science ®Google Scholar
• Chazot PL. Safinamide (Newron Pharmaceuticals). Curr. Opin. Investig. Drugs 2(6), 809–813 (2001).
   PubMedGoogle Scholar
• Fariello RG. Safinamide. Neurotherapeutics 4(1), 110–116 (2007).
   PubMed Web of Science ®Google Scholar
• 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. 50(23), 5848–5852 (2007).
   PubMed Web of Science ®Google Scholar
• Müller T, Przuntek H, Rieks M, and Mackowiak A. Selegiline reduces cisplatin-induced neuronal death in neuroblastoma cells. Neurol. Res. 30(4), 417–419 (2008).
   PubMed Web of Science ®Google Scholar
• Schapira AH, Olanow CW. Neuroprotection in Parkinson disease: mysteries, myths, and misconceptions. JAMA 291(3), 358–364 (2004).
   PubMed Web of Science ®Google Scholar
• Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA 287(13), 1653–1661 (2002).
   PubMed Web of Science ®Google Scholar
• Whone AL, Watts RL, Stoessl AJ et al. Slower progression of Parkinson’s disease with ropinirole versus levodopa: The REAL-PET study. Ann. Neurol. 54(1), 93–101 (2003).
   PubMed Web of Science ®Google Scholar
• Clarke CE. A “cure” for Parkinson’s disease: can neuroprotection be proven with current trial designs? Mov. Disord. 19(5), 491–498 (2004).
   PubMed Web of Science ®Google Scholar
• Clarke CE. Neuroprotection and pharmacotherapy for motor symptoms in Parkinson’s disease. Lancet Neurol. 3(8), 466–474 (2004).
   PubMed Web of Science ®Google Scholar
• Morrish P. Is it time to abandon functional imaging in the study of neuroprotection? Mov. Disord. 17(2), 229–232 (2002).
   PubMed Web of Science ®Google Scholar
• Goetz CG, Leurgans S, Raman R. Placebo-associated improvements in motor function: comparison of subjective and objective sections of the UPDRS in early Parkinson’s disease. Mov. Disord. 17(2), 283–288 (2002).
   PubMed Web of Science ®Google Scholar
• Jankovic J, McDermott M, Carter J et al. Variable expression of Parkinson’s disease: a base-line analysis of the DATATOP cohort. The Parkinson Study Group. Neurology 40(10), 1529–1534 (1990).
   PubMed Web of Science ®Google Scholar
• Parkinson Study Group. Impact of deprenyl and tocopherol treatment on Parkinson’s disease in DATATOP patients requiring levodopa. Ann. Neurol 39(1), 37–45 (1996).
   PubMed Web of Science ®Google Scholar
• Fernandez HH, Chen JJ. Monoamine oxidase-B inhibition in the treatment of Parkinson’s disease. Pharmacotherapy 27(12 Pt 2), 174S–185S (2007).
   PubMed Web of Science ®Google Scholar
• Przuntek H, Conrad B, Dichgans J et al. SELEDO: a 5-year long-term trial on the effect of selegiline in early Parkinsonian patients treated with levodopa. Eur. J. Neurol. 6(2), 141–150 (1999).
   PubMed Web of Science ®Google Scholar
• Parkinson Study Group. A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease. Arch. Neurol. 61(4), 561–566 (2004).
   PubMed Web of Science ®Google Scholar
• Olanow C, Rascol O. The ADAGIO Study: Secondary and additional endpoints. Neurology 72(Suppl. 3), S42.008 (2009).
   Google Scholar
• 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. 62(2), 241–248 (2005).
   PubMed Web of Science ®Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• Stern MB, Marek KL, Friedman J et al. Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson’s disease patients. Mov. Disord. 19(8), 916–923 (2004).
   PubMed Web of Science ®Google Scholar
• Caccia C, Maj R, Calabresi M et al. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology 67(7 Suppl. 2), S18–S23 (2006).
   PubMed Web of Science ®Google Scholar
• Morsali D, Bechtold D, Lee W et al. Safinamide and flecainide protect axons and reduce microglial activation in models of multiple sclerosis. Brain 136(Pt 4), 1067–1082 (2013).
   PubMed Web of Science ®Google Scholar
• Cattaneo C, Caccia C, Marzo A, Maj R, Fariello RG. Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition. Clin. Neuropharmacol. 26(4), 213–217 (2003).
   PubMed Web of Science ®Google Scholar
• Fariello RG, McArthur RA, Bonsignori A et al. Preclinical evaluation of PNU-151774E as a novel anticonvulsant. J. Pharmacol. Exp. Ther. 285(2), 397–403 (1998).
   PubMed Web of Science ®Google Scholar
• 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 67(7 Suppl. 2), S24–S29 (2006).
   PubMed Web of Science ®Google Scholar
• Strolin Benedetti MS, Marrari P, Colombo M et al. The anticonvulsant FCE 26743 is a selective and short-acting MAO-B inhibitor devoid of inducing properties towards cytochrome P450-dependent testosterone hydroxylation in mice and rats. J. Pharm. Pharmacol. 46(10), 814–819 (1994).
   PubMed Web of Science ®Google Scholar
• Strolin BM, Tocchetti P, Rocchetti M et al. Enantioselective recognition of two anticonvulsants, FCE 26743 and FCE 28073, by MAO, and relationship between MAO-B inhibition and FCE 26743 concentrations in rat brain. Prog. Brain Res. 106, 123–134 (1995).
   PubMed Web of Science ®Google Scholar
• Gregoire L, Jourdain VA, Townsend M, Roach A, Di PT. Safinamide reduces dyskinesias and prolongs l-DOPA antiparkinsonian effect in parkinsonian monkeys. Parkinsonism Relat. Disord. 19(5), 508–514 (2013).
   PubMed Web of Science ®Google Scholar
• Podurgiel S, Collins-Praino LE, Yohn S et al. Tremorolytic effects of safinamide in animal models of drug-induced parkinsonian tremor. Pharmacol. Biochem. Behav. 105, 105–111 (2013).
   PubMed Web of Science ®Google Scholar
• Stocchi F, Arnold G, Onofrj M et al. Improvement of motor function in early Parkinson disease by safinamide. Neurology 63(4), 746–748 (2004).
   PubMed Web of Science ®Google Scholar
• Stocchi F, Borgohain R, Onofrj M, et al. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson’s disease patients. Mov. Disord. 27(1), 106–112 (2012).
   PubMed Web of Science ®Google Scholar
• Schapira AH, Stocchi F, Borgohain R, Onofrj M, Bhatt M, Lorenzana P, Lucini V, Giuliani R, and Anand R. Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson’s disease. Eur. J. Neurol. 20(2), 271–280 (2013).
   PubMed Web of Science ®Google Scholar
• Barone P, Fernandez HH, Ferreira J et al. Safinamide as an add-on therapy to a stable dose of a single dopamine agonist: results from a randomized, placebo-controlled, 24-week multicenter trial in early idiopathic Parkinson Disease (PD) patients (MOTION Study). Neurology 80 (Meeting Abstracts 1) (2013).
   PubMed Web of Science ®Google Scholar
• Merck, Serono, Newron. Press release. data on file (2009).
   Google Scholar
• Schapira AH, Fox SH, Hauser RA et al. Safinamide add on to L-Dopa: a randomized, placebo-controlled, 24-week global trial in patients with Parkinson’s Disease (PD) and motor fluctuations (SETTLE). Neurology 80 (Meeting Abstracts 1) (2013).
   PubMed Web of Science ®Google Scholar
• Thomas A, Iacono D, Luciano AL, Armellino K, Di Iorio A, Onofrj M. Duration of amantadine benefit on dyskinesia of severe Parkinson’s disease. J. Neurol. Neurosurg. Psychiatry 75(1), 141–143 (2004).
   PubMed Web of Science ®Google Scholar
• Müller T, Erdmann C, Muhlack S et al. Pharmacokinetic behaviour of levodopa and 3-O-methyldopa after repeat administration of levodopa/carbidopa with and without entacapone in patients with Parkinson’s disease. J. Neural. Transm. 113(10), 1441–1448 (2006).
   PubMed Web of Science ®Google Scholar
• Hauser RA, Silver D, Choudry A, Isaacson S. A placebo controlled, randomized, double-blind study to assess the safety and clinical benefit of rasagiline as an add-on therapy to dopamine agonist monotherapy in early Parkinson’s disease (PD): The ANDANTE study. Neurology 80 (Meeting Abstracts 1) (2013).
   Google Scholar
• Dimpfel W, Hoffmann JA. Effects of rasagiline, its metabolite aminoindan and selegiline on glutamate receptor mediated signalling in the rat hippocampus slice in vitro. BMC Pharmacol. 11, 2 (2011).
   PubMedGoogle Scholar
• Adler CH, Caviness JN, Hentz JG, Lind M, Tiede J. Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson’s disease. Mov. Disord. 18(3), 287–293 (2003).
   PubMed Web of Science ®Google Scholar