Newron Pharmaceuticals SpA, a research and development company focused on central nervous system (CNS) and pain therapies, reports that it has completed its initial series of meetings with European health authorities relating to the results of the preclinical, CMC, and clinical studies to support registration of safinamide as add-on therapy for the treatment of both early (non-fluctuating) and advanced (fluctuating) patients with idiopathic Parkinson’s disease (PD). Safinamide is being developed by Newron and its partners Zambon Pharma S.p.A. and Meiji Seika Pharma Co. Ltd.
The health authorities agreed with the adequacy of the safinamide program for preclinical toxicology, CMC, DMPK, and the size of the clinical safety data base that will be part of the submission. In addition, they provided feedback on the results of the studies demonstrating statistically significant efficacy of safinamide as add-on therapy in patients taking a stable dose of a single dopamine agonist in early PD patients, as measured by the UPDRS Part III (primary efficacy measure), and on motor fluctuations (measured by ON time; primary efficacy measure) in patients with advanced PD on levodopa and other PD treatments. Based on this feedback, Newron will proceed to meet with additional European health authorities, EMA and FDA to discuss its plans for global regulatory submission currently expected in second half of 2013.
The efficacy and safety of safinamide as add-on to a stable dose of a single dopamine agonist was evaluated in patients with early PD in three placebo-controlled studies (009, 015, MOTION), while its therapeutic benefits as add-on to levodopa and other PD treatments in patients with advanced PD were studied in two placebo-controlled studies (016, SETTLE). The presentation of the results of the recently completed MOTION and SETTLE studies has been scheduled for the 2013 AAN Annual Meeting, San Diego, USA, March 16-23, 2013.
Date: November 14, 2012
Source: Newron Pharmaceuticals SpA