Newron and Merck Serono’s Safinamide misses goal in pivotal Parkinson's phase III study
Milan/Geneva – Italian drugmaker Newron Pharmaceuticals and its partner Merck Serono have failed to demonstrate that its investigational drug Safinamide provides a significant benefit as a treatment for advanced Parkinson’s disease as an add-on therapy to levodopa. In a three-arm phase III extension study, neither a 50 mg nor a 100 m mg once daily dose of the drug achieved the primary efficacy study endpoint of improving dyskinesia after 24 months of treatment. However, safety was confirmed in the study involving 544 patients. Dyskinesia, which consists of involuntary and twisting movements of the face and body, is a major complication of levodopa therapy, resulting in a significant deterioration of patient quality of life. At baseline, 32% of patients showed troublesome dyskinesia. The companies’ goal is to file a MAA for their alpha-aminoamide MAO-B blocker as an add-on therapy for dopamine agonist therapy in patients with early Parkinson's disease, and as an add-on for levodopa therapy in patients with advanced Parkinson's.