Newron Pharmaceuticals and its partner Zambon has announced that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the use of Xadago (safinamide) as add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of patients with mid-late stage Parkinson’s disease experiencing motor fluctuations despite being stabilised on ‘Standard of Care’.
C Warren Olanow, Henry P and Georgette Goldschmidt, professor and chairman Emeritus of the Department of Neurology and Professor of Neuroscience at the Mount Sinai School of Medicine, states: “Safinamide is the first NCE to be approved for the treatment of Parkinson’s disease in the past 10 years. In a two year double blind study, the product demonstrated rapid onset of efficacy (within two weeks) and benefit with respect to improvements in ‘ON and OFF Time’ without an increase in dyskinesia. This was maintained for the two year duration of the trial when used as an add-on treatment to Parkinson’s disease patients with L-dopa-induced motor fluctuations, compared with Standard of Care. No other agent has demonstrated this duration of benefit in a double blind trial.
Safinamide’s effects are dependent upon pharmacological mechanisms that are not shared with other Parkinson’s disease drugs. These effects include its dual mechanism of highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels that inhibit glutamate release, implicated in causing dyskinesia. Preclinical experiments and data from a large number of dyskinetic patients enrolled in a placebo controlled clinical study indicate that safinamide also has the potential to improve L-dopa induced dyskinesia in Parkinson’s disease patients.”
Fabrizio Stocchi, professor of Neurology, director of the Parkinson’s Disease and Movement Disorders Research Centre, and Institute for Research and Medical Care IRCCS San Raffaele, Rome, who has been involved with safinamide trials from the beginning, says: “The benefits of safinamide were demonstrated as adjunctive treatment for fluctuating patients on top of L-dopa alone or in combination with other Parkinson’s disease medications. Safinamide demonstrated significantly improved motor fluctuations, Parkinsonism, Quality of Life and Activities of Daily Living without any increase in ‘ON Time with troublesome dyskinesia’.
My experience in treating Parkinson’s disease patients with safinamide in Rome over the last 10 years, as well as my review of all the data indicate that safinamide is extremely well tolerated even over long periods of time. Safinamide does not require any specific medical monitoring, dietary restrictions, or particular precautions because the risk of drug interactions is very low.”
The CHMP’s positive opinion on Xadagowill now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.
The EU filing was based on results of a comprehensive development programme comprising over 300 preclinical studies and 37 clinical studies performed in over 30 countries worldwide, with over 3,000 subjects treated, and safinamide’s safety being documented in >1,100 patients for one year, >500 patients for two years, >220 patients for >three years, and >160 patients for four years.