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Old 03-26-2014, 02:31 PM
ashleyk ashleyk is offline
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Join Date: Oct 2006
Location: New England
Posts: 262
15 yr Member
ashleyk ashleyk is offline
Member
 
Join Date: Oct 2006
Location: New England
Posts: 262
15 yr Member
Default safinamide. Get it to market now?

I noticed that there are many phase 1 and 2 trials but few phase 3. And application to market a new drug seems to go nowhere with the FDA. Maybe they know what they are doing or maybe they see no urgency to do anything.
In any event there seems to be a drug in phase 3 for advanced PD which seems very helpful for quality of life, safinamide. Is this study going to be put on the shelf or fast tracked by the FDA? People with 10 or more years of PD are running out of time.

http://www.ncbi.nlm.nih.gov/pubmed/24323641
Abstract

Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia. © 2013 International Parkinson and Movement Disorder Society.
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