Safinamide is an oral, once a day adjunctive therapy for any stage of Parkinson's disease (PD). It is a unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of the excessive release of glutamate.
Safinamide, has completed the Phase III development programme and filing for regulatory approval as add-on therapy in early and mid-to late PD patients in the EU and US is expected in Q4 2013.
Safinamide is partnered with Meiji Seika Pharma Co., Ltd., a subsidiary of the Meiji Holdings Co., Ltd., in Japan and key Asian territories and with Zambon Group in all other markets, including the US and Europe.
Results from the last out-standing Phase III studies, MOTION and SETTLE, have been presented during the 2013 American Academy of Neurology (AAN), the Mental Dysfunction & Other Non-Motor Features in Parkinson’s Disease and Related Disorders (MDPD) and the Movement Disease Society (MDS) annual meetings and conferences. The results confirmed earlier findings thatsafinamide significantly improves motor function in early PD patients on a single dopamine agonist at a stable dose (MOTION study) andsignificantly improves motor fluctuations in mid-to late stage PD patients on levodopa and other PD drugs at a stable dose (SETTLE study). Furthermore, both short (6 months) and long term (18 -24 months) treatment with safinamide has shown statistically significant improvement in Quality of Life, as assessed by the Parkinson’s disease Quality of Life (PDQ-39) and/or the European Quality of Life (EuroQoL, EQ-5D) scales.
The MOTION study was a six-month (24-week), randomized, double-blind, placebo controlled international Phase III trial. It enrolled patients with early idiopathic PD (less than five years of disease duration) treated with a stable dose of a single dopamine agonist for at least four weeks. 679 patients were randomized equally to receive once daily safinamide 50 mg, or 100 mg, or matching placebo tablets as adjunctive treatment to a single dopamine agonist at a fixed dose. In accordance with international regulatory guidelines, the primary efficacy variable of the trial was the change in motor symptoms assessed by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score from baseline to week 24.
The SETTLE study was a six-month (24-week), randomized, double-blind, placebo controlled international Phase III trial. It enrolled 549 patients with mid-to late-stage idiopathic PD (more than three years of disease duration) treated with optimized, stable doses of levodopa and standard of care (dopamine agonist, COMT inhibitor, anticholinergic and/or amantadine) for at least four weeks. Patients who were experiencing a minimum of one and a half hours of “OFF” time during the day were randomized equally to treatment with once a day safinamide (50-100mg) or placebo (standard of care including levodopa), as adjunctive treatment. Based on discussions with the regulatory authorities, the primary endpoint of the trial was the change in daily “ON” time, as assessed by the patient completed daily diary cards (18 hours/day).