"This data is promising for patients with Parkinson's disease," said Fabrizio Stocchi, Professor of Neurology at the University La Sapienza, and principal investigator of the study. "The data not only shows the benefits of Safinamide on motor symptoms and activities of daily living, but also indicates an effect on cognitive performance, which may represent a major advantage for patients."
The data demonstrated that the addition of Safinamide to a stable dose of a single dopamine agonist in patients with early stage Parkinson's disease resulted in a statistically significant improvement in motor symptoms. After 24 weeks of treatment with Safinamide at the dose of 50 to 100 mg once daily, the UPDRS Motor Score was significantly improved over the effect of dopamine agonist monotherapy. In addition, study patients taking Safinamide at the dose of 50 to 100 mg once daily over a 24-week period experienced a significant improvement in activities of daily living.
Researchers also measured Safinamide's effects on cognition. Compared with patients on dopamine agonist, monotherapy, the addition of Safinamide was associated with improvement. Researchers used tests assessing spatial working memory, strategic target detection and auditory number sequencing.
The side effects observed in the Safinamide group were similar to those observed in the placebo group.
The trial was conducted in Europe, South America and Asia. A total of 270 early stage Parkinson's disease patients (suffering less than 5 years with the disease) were treated with a stable dose of a single dopamine agonist for at least 4 weeks, and were randomized to one of the three arms of the study to receive either Safinamide at a dose of 50 to 100 mg once daily (90 patients), or Safinamide at a dose of 150 to 200 mg once daily (90 patients) or matching placebo tablets (90 patients), as an add-on treatment to dopamine agonist therapy.
The higher Safinamide dose-range of 150 to 200 mg per day did not offer any incremental advantage over the Safinamide 50 to 100 mg per day dose-range, based on UPDRS scoring.
A one-year (52-week) extension phase of this study is ongoing. A second Phase III pivotal study of Safinamide, in patients with mid-to-late stage Parkinson's disease with motor fluctuations, treated with a stable dose of levodopa, was initiated in November 2006.
Studies suggest that Safinamide may combine the inhibition of dopamine re-uptake (keeps the dopamine in a person's body longer) and MAO-B (a chemical that breaks down dopamine), two key mechanisms involved in the control of dopamine concentration in the brain. Meaning it may very well reduce the amount of Levodopa that a person with Parkinson's disease would need to take.
So, at this point, Safinamide has a reasonably good chance of making it to a pharmacy near you. We'll guess that it has a 75% chance of making it to American Parkinson's disease patients within the next three years.