Safinamide shows promising Ph3 results against dyskinesia

Merck Serono and Newron Pharmaceuticals may have a promising new add-on treatment for Parkinson's disease sufferers. According to data from an extension of a previous Phase III trial, the company's safinamide lowered patients' dyskinesia rating scale scores in severe cases when the drug was administered at 100 mg with levodopa, a common Parkinson's treatment.

"Improvement in dyskinesia is the Holy Grail of Parkinson's treatments," Dr. Ravi Anand, a consultant for Newron, said in an interview, as quoted by Medscape. "Safinamide improved nominal motor fluctuations, parkinsonism, activities of daily living, depressive symptoms and quality of life without worsening dyskinesia. We hope to be the first drug with both indications."

Safinamide is a monoamine oxidase B inhibitor and works by suppressing dopamine reabsorption and the release of glutamate. Although the drug showed good results in patients with initial dyskinesia scores of four--the highest on the one to four scale--it didn't lower scores overall in the two-year, 440-patient study. In November, the drug missed its primary efficacy goals in a Phase III study.

Merck and Newron hope to submit the drug for FDA approval next year. The study results were presented at the 63rd Annual Meeting of the American Academy of Neurology.

- here's the Merck Serono release
- read the story from The Telegraph
- see the Medscape report