29 March 2016 - Newron Pharmaceuticals and US WorldMeds announced today that a complete response letter from the FDA has been received for safinamide. The complete response letter requests clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff in the Center for Drug Evaluation and Research at the FDA.

Ravi Anand, MD, CMO, said: “The complete response letter does not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease. Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalize plans for the additional experiments”.

For more details, go to: http://www.newron.com/ENG/Default.aspx?SEZ=5&PAG=19&MOD=NWRPRS