SAFINAMIDE CLINICAL TRIAL RESULTS

6th September 2013 - New research European Journal of Neurology [2013] September 11 [Epub ahead of print]   (A.H.Schapira, F.Stocchi, R.Borgohain,  M.Onofrj, M.Bhatt, P.Lorenzana, V.Lucini, R.Giuliani, R.Anand)  Safinamide is believed to have both dopaminergic and non-dopaminergic  actions, including the inhibition of MAO-B and inhibition of glutamate release.  It is undergoing  Phase III clinical development as a once-daily add-on to  dopamine agonists for the treatment of early Parkinson's Disease. In a one year clinical trial people with Parkinson's  Disease received 100mg or 200mg Safinamide daily.  They were assessed according to how long it was   before they had to increase their dopamine agonist dose  or add another Parkinson's Disease treatment.  People receiving 100 mg/day safinamide experienced  a significantly lower rate of intervention compared with placebo, of 25%  instead of 51% and a small delay before the need to increase other  Parkinson's Disease treatments of 9 days. In a previous study of once daily dosages of 50mg to 100mg Safinamide  improved Parkinson's Disease symptoms after six months and reduced  "off" time when added on to the use of existing Parkinson's Disease  treatments. However, the reduction in "off" time in comparison to  the use of a placebo was minimal. The increase in "on" time beyond  that of a placebo was only 40 minutes for 50mg safinamide, and 50 minutes  for 100mg safinamide.