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| Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represent the opinions of the authors and are not endorsed by nor do they reflect the views of the American Academy of Neurology, Editor-in-Chief, or Associate Editors of Neurology. |
From the IRCCS San Raffaele Pisana, Rome Italy (F.S., P.G.), IRCCS NEUROMED Pozzilli IS Italy, San Raffaele Cassino FR Italy (L.V., G.B.), Newron Pharmaceuticals Bresso (Milano), Italy (C.C.), and Department of Neurology, T. Jefferson University, Philadelphia, Pennsylvania (R.G.F.).
Address correspondence and reprint requests to Dr. Ruggero Fariello, Newron Pharmaceuticals spa, Via Ludovico Ariosto 21, 20091 Bresso (MI), Italy; e-mail: ruggero{at}fariello.com
In an open pilot study, doses of safinamide (100, 150, and 200 mg once a day, higher than previously tested) were administered to 13 parkinsonian patients along with a stable dose of dopamine (DA) agonist, causing a significant progressive improvement in motor performance as evaluated by the Unified Parkinson Disease Rating Scale (UPDRS) part III over an 8-week period (4.2 points; P < 0.001). In association with levodopa, the same doses of safinamide in another group of patients (N = 11) induced a significant decrease in motor fluctuations (UPDRS part IV, 2.1 points; P < 0.001), accompanied by a dose-proportional increase of the levodopa AUC, up to 77% from baseline. Because MAO-B was fully inhibited (95%) at all doses tested, we suggest that these biochemical and symptomatic dose-dependent effects must be related to additional mechanisms of action, such as inhibition of glutamate release, increased dopamine release, or inhibition of dopamine re-uptake. These hypotheses are under investigation and will pursue confirmation in controlled clinical trials.
Publication of this supplement was supported by a grant from Newron Pharmaceuticals.
Disclosure: The sponsor has provided F.S. with an honorarium for his participation in this project (in excess of $10,000) and honorarium during his career (in excess of $10,000). G.B. has received grant support from the sponsor during his career. R.G.F. was an employee of the sponsor until May 2005. C.C., L.V., M.F.D.P., and P.G. report no conflicts of interest.
Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represents the opinions of the authors and is not endorsed by nor does it reflect the views of the American Academy of Neurology, Editorial Board, Editor-in-Chief, or Associate Editors of Neurology.
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