Newron ($NWRN) and Merck KGaA's safinamide failed to perform in a Phase III study of the drug for the involuntary movements associated with Parkinson's disease. The study was designed to test the long-term efficacy and safety of two doses of safinamide. Although the primary efficacy endpoint was not met, the companies were encouraged by the data that confirms the safety profile of safinamide and its effect on motor function observed in the six-month study in this advanced Parkinson's disease population. "The effect of safinamide on dyskinesia will be further explored in an ongoing dedicated pilot study," explains Dr. Bernhard Kirschbaum, Merck Serono's Head of Global R&D.
Jefferies analysts told Reuters that while the companies will have to wait on the dyskinesia indication, they'll still be able to submit the drug for the treatment of advanced Parkinson's disease.
- see Merck's release
- check out the report from Reuters