LONDON, January 19, 2017 /PRNewswire/ --
New Review of Safinamide - A New Therapeutic Option to Address Motor Symptoms and Motor Complications in Mid- to Late-stage Parkinson's Disease
C Warren Olanow, Fabrizio Stocchi, European Neurological Review,2016;11(Suppl. 2): 2-15, http://www.touchneurology.com/articles/safinamide-new-therapeutic-option-address-motor-symptoms-and-motor-complications-mid-late
Published recently in a supplement to European Neurological Review the peer-reviewed journal from touchNEUROLOGY, C Warren Olanow et al, discusses a new therapeutic option in Parkinson's disease (PD). Levodopa is the cornerstone of therapy for PD and remains the most effective treatment available. Over time, however, the beneficial motor response to levodopa gradually shortens (this is known as 'wearing off') and motor complications (motor fluctuations and dyskinesias) increasingly affect so-called 'on-time'. The risk of developing motor complications is strongly linked to levodopa dose, independently of other predictive factors including disease severity. This provides a strong rationale for using other drugs, either alone or in combination with low-dose levodopa, to preserve the efficacy of levodopa for as long as possible. Several classes of drugs, including dopamine agonists, catechol-O-methyltransferase inhibitors, and monoamine oxidase B (MAO-B) inhibitors, are used as add-ons to levodopa, but all have significant drawbacks. Recently, safinamide (Xadago®) was approved for the treatment of PD patients as an add-on therapy to levodopa alone or in combination with other PD agents in mid- to late-stage fluctuating patients. Safinamide has a dual mechanism of action that includes modulation of dopaminergic metabolism through selective, reversible inhibition of MAO-B, and blockade of voltage and use-dependent sodium (Na+) channels, leading to inhibition of stimulated glutamate release. This article reviews the pathophysiology of PD and current treatment options, together with a comprehensive discussion of the pharmacokinetic, preclinical and clinical data relating to safinamide, including results from the 016/018 and the Safinamide in Idiopathic Parkinson's Disease With Motor Fluctuations, as add-on to Levodopa (SETTLE) studies and exploratory post hoc analyses. In these pivotal studies, safinamide 50-100 mg/day demonstrated efficacy in the treatment of motor fluctuations and motor symptoms in stabilised levodopa patients (improving the Unified Parkinson's Disease Rating Scale III score, and motor complications, as indicated by a significant reduction versus placebo in the primary endpoint of on-time without troublesome dyskinesias). Safinamide treatment was also effective for improving other motor complications (such as 'off-time', early-morning akinesia), motor symptoms, non-motor symptoms, activities of daily living and quality of life. These effects have been proved in the short term (six months) and maintained in the long term (24 months). Together, the data suggest that safinamide could be an appropriate choice as a first-line add-on therapy to levodopa in PD patients experiencing motor fluctuations.
The full peer-reviewed, open-access article is available here:
Disclosure: Fabrizio Stocchi receives consultant fees and honoraria for educational symposia from Zambon and has been a consultant to TEVA, Novartis, GSK, Lundbeck, Merck Serono, MSD, UCB, Chiesi Pharma, IMPAX, Newron, Zambon and Britannia. C. Warren Olanow receives consultant fees from Abbvie, Addex, Lundbeck, Newron, Novartis, Teva, Zambon. He is on the board for Michael J Fox Foundation, National Space Board Research Institute, Zambon. He has stock in Clintrex which provides consulting services for AstraZeneca, Accorda/Civitas, Biotie, Britannia, Corium, Cynapsus, Cytokinetics, Dart, EMD Serono, Flex, Forward, GeNeuro, Intec, Jazz, Melior, Michael J Fox Foundation, Lundbeck, Lysosomal Therapeutics, Medday, Neuroderm, Neuromedix, Neuropore, Osmotica, Otonomy, Otsuka/INC, Pfizer, Pharma2B, Prana, Raptor, Remedy, Sanofi/Genzyme, Serina, Sunovion, Synagile, Teva, Titan, Ultragenyx, Upsher Smith, US WorldMeds, Vaccinex, Weston Foundation.
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