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.
After the completion of the phase III development programme; Newron is working towards global approval of the compound, together with its partners
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 that safinamide 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.
In Europe, Newron was delighted to hear that the CHMP has recommended approval of Xadago® (safinamide) to treat Parkinson´s disease in the European Union, followed by the Marketing Authorization received from the EU Commission in February 2015. The approval covers the indication “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.
This is the first New Chemical Entity (NCE) in 10 years to receive a Marketing Authorization from the EU Commission for the treatment of Parkinson’s disease and Newron believes it could offer significant improvement to the quality of life of those living with this condition.
In July, Newron received a refusal to file (RTF) letter from the US FDA for the use of Xadago® (safinamide) as add-on therapy for patients with Parkinson’s disease. The RTF letter did not relate to the acceptability of the clinical data, and no judgment was made on the efficacy or safety of Xadago® (safinamide). Newron has since then worked closely with the FDA to resolve the organization and navigation problems with the application and has resubmitted the New Drug Application (NDA) to the FDA in December 2014. It is with great satisfaction that the Company has announced on March 2, 2015 the acceptance for filing of the NDA by the FDA.