Newron Pharmaceuticals SpA, a clinical-stage company focused on developing novel CNS therapies, has obtained IND (Investigational New Drug) approval from the US Food and Drug Administration (FDA) to evaluate safinamide as a treatment for Parkinson's disease.

Under this IND, a protocol has been approved to assess the safety of safinamide in 12 healthy volunteers. The trial will be conducted at the University of Vienna, Austria, under the auspices of Professor Hans Georg Eichler. The FDA approved study is being conducted to confirm that no dietary restrictions are needed while being treated with safinamide. This study will shortly be followed by efficacy studies in Parkinson's disease conducted in the USA. Safinamide is currently being evaluated in multiple Phase II trials in Europe for the treatment of Parkinson's disease and epilepsy.

"Obtaining FDA IND approval marks a crucial point in the development of safinamide. We have been encouraged by the positive data generated from European trials of this compound in both epilepsy and Parkinson's disease. Confirming these benefits in US clinical studies is now a priority for Newron," commented Stefano Rossetti, Vice President, Clinical Development for Newron Pharmaceuticals.