Safinamide raises "on" time by 1.3 hrs in Ph III trial

Italy's Newron Pharmaceuticals SpA and its partner, German drugmaker Merck Serono, says that the first Phase III trial of safinamide as  adjunctive therapy to levodopa met its primary endpoint by increasing  daily "on" time in mid- to late-stage Parkinson's disease patients with  motor fluctuations by 1.3 hours.

"On" time represents periods when Parkinson's patients experience their  best level of motor functioning. The two safinamide treatment groups of  the study (receiving either 50mg orally once daily or safinamide 100mg  orally once daily as adjunctive therapy to levodopa) showed a  statistically-significant increase compared to placebo.

Throughout the six months of the study, patients treated with both doses  of safinamide experienced an average increase of "on" time of 1.3 hours  per day compared to baseline. Patients in the placebo group (receiving  placebo in addition to levodopa and other anti-Parkinson therapies)  reported an average increase of daily "on" time of 0.7 hours compared to  baseline. The differences between both safinamide dose groups and  placebo were statistically significant (p=0.008 for the 50mg daily group  and p=0.005 for the 100mg cohort).