Safinamide (Onstryv) - idiopathic Parkinson's disease Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1. HomeSummary Basis
The effects of safinamide on dysphagia in Parkinson's disease. Dysphagia is a potentially fatal symptom of Parkinson's disease (PD) and is characterized by frequent silent aspiration, a risk factor for aspiration pneumonia. The transdermal dopamine agonist rotigotine alleviates dysphagia in patients with PD and is more effective than oral levodopa, suggesting the importance of continuous dopaminergic stimulation (CDS) in swallowing. Safinamide is a monoamine oxidase B (MAOB) inhibitor that facilitates CDS. In this retrospective open-label evaluator-blinded research, swallowing functions in nine patients with PD were examined using a video fluoroscopic swallowing study (VFSS) before and after treatment with 50 mg of oral safinamide. The VFSS results showed that safinamide significantly
Parkinson?s disease with motor fluctuations: safinamide Parkinson’s disease with motor fluctuations: safinamide Evidence summary Published: 21 February 2017 www.nice.org.uk/guidance/es6 pathwaysKey points Key points The content of this evidence summary was up-to-date in February 2017. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. Regulatory status:Regulatory status: New medicine. Safinamide is a monoamine oxidase-B (MAO-B) inhibitor. It received a European marketing authorisation in February 2015 and was launched in the UK in May 2016. It is licensed for treating mid- to late-stage idiopathic Parkinson's disease in adults who are experiencing motor fluctuations, as an add-on treatment to a stable
The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Ethnicity differences are an important determinant in the clinical manifestation of Parkinson's disease (PD), but they are not yet widely recognized, particularly regarding the response to dopaminergic medications. The aim of this paper is to analyze the efficacy and safety of safinamide in Chinese patients with PD in the pivotal studies SETTLE and XINDI compared to the non-Chinese population of the SETTLE trial. SETTLE (NCT00627640) and XINDI (NCT03881371) were phase III, randomized, double-blind, placebo-controlled, multicenter trials. Patients received safinamide or placebo as add-on to levodopa. The primary efficacy endpoint was the change in the mean total daily OFF time. Secondary efficacy endpoints
Safinamide (Xadago) for the treatment of adult patients with idiopathic Parkinson's disease Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson's disease | Report | National Health Care Institute Go to content You are here: Home Publications Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson's disease Search within English part of National Health Care Institute Search Safinamide (Xadago®) for the treatment of adult patients with idiopathic Parkinson's diseaseThe National Health Care Institute has approved a pharmacotherapeutic report for the medicine safinamide (Xadago®). They reached the following conclusion.Based on the criteria of the Medicines Reimbursement System (GVS), safinamide can be includedin the GVS on List 1A
Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study. Safinamide is a selective, reversible, monoamine oxidase B inhibitor for the treatment of patients with Parkinson's disease (PD) and motor fluctuations. This was a analysis of the SETTLE study, in which patients with PD and motor fluctuations were randomly assigned to 24-week treatment with safinamide (50 mg/day for 2 weeks, increased to 100 mg/day if tolerated) or placebo. In the present analysis, responders were defined according to their treatment responses at Week 2 and Week 24 based on changes in ON-time without troublesome dyskinesia from baseline with cutoffs of 1 hour. It was found that 81% (103/127) of the responders at Week 2
Pharmacokinetic and Safety Study of Single and Multiple Oral Doses of Safinamide in Healthy Chinese Volunteers. This randomized, parallel-group study evaluated the plasma pharmacokinetic profile of safinamide in 24 healthy Chinese men and women, randomly assigned to receive 50 or 100 mg of safinamide as a single dose, followed, after a 7-day washout, by multiple doses once daily for 7 days . Plasma safinamide was determined up to 96 h after the first single dose (day 1) and the last multiple dose (day 14), and up to 24 h after the first multiple dose (day 8). Following single- and multiple-dose administration, peak concentrations were achieved at a median time of 1.5-2 h. Plasma exposure increased in a dose-proportional manner. After single dose, mean half-life was 23-24 h. Area under
Safinamide as an Adjunct to Levodopa in Asian and Caucasian Patients With Parkinson's Disease and Motor Fluctuations: A Post Hoc Analysis of the SETTLE Study. Safinamide is a selective, reversible monoamine oxidase B inhibitor with demonstrated efficacy and tolerability in placebo-controlled studies and is clinically useful for patients with motor fluctuations. This study evaluated the efficacy and safety of safinamide as a levodopa adjunct therapy in Asian patients with Parkinson's disease. Data from 173 Asian and 371 Caucasian patients from the international Phase III SETTLE study were included in this post hoc analysis. The safinamide dose was increased from 50 mg/day to 100 mg/day if no tolerability issues occurred at week 2. The primary outcome was the change from baseline to week 24
Pharmacokinetics and Bioequivalence of 2 Safinamide Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions. To assess the bioequivalence of a generic safinamide tablet (test) vs a brand-name safinamide tablet (reference) and effects of food on the pharmacokinetics of safinamide in healthy Chinese subjects, a single-center, single-dose, randomized, open-label, 2-preparation, 2 -period study with a 15-day washout period was undertaken. A total of 56 healthy subjects were recruited in this study (fasting, n = 28; fed, n = 28). A single dose of a 100-mg test or reference safinamide tablet was administered to each subject in a randomized sequence. Blood samples were obtained at 5 minutes before drug administration and during the 120 hours after dosing. The safinamide
The effects of safinamide according to gender in Chinese parkinsonian patients. The incidence and prevalence of Parkinson's disease (PD) is expected to raise dramatically over the next decades. Gender-related differences are not yet widely recognized, particularly regarding the response to dopaminergic medications. To analyse gender differences in the clinical effects of safinamide, compared to placebo, in Chinese PD patients of the pivotal XINDI trial. The XINDI study was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Patients were followed for 16 weeks receiving safinamide or placebo as add-on to levodopa. The primary efficacy endpoint was the change in the mean total daily OFF time. Secondary efficacy endpoints included total daily ON time, ON time with no/non
Safinamide: benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Safinamid – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 August 2015). Please note: This translation is provided as a service by IQWiG to English-language readers . However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A15-18 Safinamide – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A15-18 Version 1.0 Safinamide – Benefit assessment acc. to §35a Social Code Book V 13 August 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing
Safinamide (Addendum to Commission A15-18) Safinamid (Addendum zum Auftrag A15-18) Addendum 29.10.2015 1.1 Auftrag: A15-41 Version: Stand: IQWiG-Berichte – Nr. 332 Addendum A15-41 Version 1.1 Safinamid (Addendum zum Auftrag A15-18) 29.10.2015 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - i - Impressum Herausgeber: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Thema: Safinamid (Addendum zum Auftrag A15-18) Auftraggeber: Gemeinsamer Bundesausschuss Datum des Auftrags: 22.09.2015 Interne Auftragsnummer: A15-41 Anschrift des Herausgebers: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 (KölnTurm) 50670 Köln Tel.: +49 (0)221 – 35685-0 Fax: +49 (0)221 – 35685-1 E-Mail: berichte@iqwig.de Internet
A Randomized Clinical Trial to Evaluate the Effects of Safinamide on Apathetic Non-demented Patients With Parkinson's Disease. Apathy is highly prevalent and disabling in Parkinson's disease (PD). Pharmacological options for its management lack sufficient evidence. We studied the effects of safinamide on apathy in PD. Prospective, 24-week, two-site, randomized, double-blind, placebo-controlled , parallel-group exploratory study in non-demented PD on stable dopaminergic therapy randomized 1:1 to adjunct safinamide (50 mg/day for 2 weeks and 100 mg/day for 22 weeks) or placebo. The primary endpoint was the mean change from baseline to week 24 on the Apathy Scale (AS) total score. Secondary endpoints included changes in cognition, activities of daily living, motor scores, the impression of change
Long-term effects of safinamide adjunct therapy on levodopa-induced dyskinesia in Parkinson's disease: post-hoc analysis of a Japanese phase III study. This post-hoc analysis investigated the long-term effects of safinamide on the course of dyskinesia and efficacy outcomes using data from a phase III, open-label 52-week study of safinamide 50 or 100 mg/day in Japanese patients with Parkinson's III, and Part II [OFF-phase] scores. The cumulative incidence of new or worsening dyskinesia (adverse drug reaction) at Week 52 was 32.5 and 5.0% in the pre-D and Without pre-D subgroups, respectively. This study suggested that safinamide led to short-term increasing dyskinesia but may be not associated with marked dyskinesia at 1-year follow-up in patients with pre-existing dyskinesia
The Effects of Safinamide Adjunct Therapy on Depression and Apathy in Patients With Parkinson's Disease: Post-hoc Analysis of a Japanese Phase 2/3 Study. Neuropsychiatric symptoms in Parkinson's disease (PD) have been shown to significantly affect quality of life (QOL). We investigated the impact of safinamide on depression and apathy when administered as an adjunct to levodopa in Japanese patients with PD. This was a analysis of data from a phase 2/3 clinical study of safinamide in Japanese patients with PD experiencing wearing-off (JapicCTI-153056; https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-153056). Patients received placebo, safinamide 50 mg, or safinamide 100 mg as an adjunct therapy. The endpoints for this analysis were changes from baseline to Week
The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson's Disease with Motor Fluctuations. Levodopa remains the gold standard for the treatment of Parkinson's disease, but its long-term use is associated with motor complications whose management is still a significant challenge . Safinamide is a multimodal drug with proven efficacy as an adjunct to levodopa. The objective of this study was to investigate the efficacy and safety of safinamide as an add-on to levodopa in Chinese patients with Parkinson's disease with motor fluctuations. The XINDI study was a phase III, randomized, double-blind, placebo-controlled, multicenter study, with a 2-week screening period and a 16-week
Effects of safinamide adjunct therapy on pain in patients with Parkinson's disease: Post hoc analysis of a Japanese phase 2/3 study. The non-dopaminergic and dopaminergic actions of safinamide may alleviate pain in patients with Parkinson's disease (PD). We investigated the efficacy of safinamide for pain when administered as an adjunct to levodopa in Japanese patients with PD. This was a post hoc analysis of a phase 2/3 clinical study of safinamide in Japanese patients with PD who were experiencing wearing-off. Pain was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) Part II 'sensory symptoms' item 17, on a scale of 0-4, and the 39-item Parkinson's Disease Questionnaire (PDQ-39) 'bodily discomfort' domain score. Subgroup analyses, according to baseline symptoms
Effects of safinamide on REM sleep behavior disorder in Parkinson disease: A randomized, longitudinal, cross-over pilot study. Rapid Eye Movement sleep behavior disorder (RBD) is characterized by dream enactment and loss of muscle atonia during REM-sleep. RBD as a premotor feature occurred souvent in patients who develop Parkinson's disease. The glutamatergic, glycinergic, and GABA-ergic systems appear to play a crucial role in the pathogenesis of RBD. The present exploratory longitudinal cross-over study aimed to observe the effect of safinamide on RBD symptoms. Thirty patients with PD and RBD were randomized into two groups (15 subjects each), those that received for a period of 3-months safinamide (50 mg/die) in addition (Group A + ) or in absence (Group B - ) to the usual antiparkinsonian