Safinamide (INN; brand name Xadago) is a drug used as an add-on treatment for Parkinsons disease with "off" episodes; it has multiple modes of action, including the inhibition of monoamine oxidase B.It was approved in the European Union in February 2015, in the United States in March 2017, and in Canada in January 2019. Medical uses
Safinamide is used to treat idiopathic Parkinsons disease as add-on for people taking a stable dose of levodopa (L-dopa) alone or in combination with other Parkinson drugs, to help with "off" episodes when levodopa stops working. Contraindications
Safinamide is contraindicated in people with severe liver impairment, with albinism, retinitis pigmentosa, severe diabetic neuropathy, uveitis and other disorders of the retina. Combination with other monoamine oxidase (MAO) inhibitors and pethidine is also contraindicated.It is not safe for women to take during pregnancy. It is excreted in breast milk and the effects on infants are unknown. Adverse effects
Common adverse events in clinical trials (in more than 1% of people) included nausea, dizziness, tiredness, sleeplessness, orthostatic hypotension (low blood pressure), and headache. There was no significant difference in the occurrence of these effects between safinamide and placebo.In experiments with rats (but not in those with monkeys), retinopathies have been observed. Overdose
Expected overdose effects are hypertension (high blood pressure), orthostatic hypotension, hallucinations, psychomotor agitation, nausea, vomiting, and dyskinesia. In studies, a single person was suspected to have overdosed for a month; symptoms were confusion, drowsiness and mydriasis (dilation of the pupils) and subsided completely after the drug was discontinued. No specific antidote is available.
In October 2011 Merck, now Merck-Serono, announced that they would give all rights to develop the compound back to Newron because they wanted to prioritise other projects and had corrected their estimates for safinamides market potential downwards.The US Food and Drug Administration (FDA) refused to file Newrons application in 2014 on formal grounds. Newron re-applied in December 2014. In spring 2015, following a commercial agreement between Newron and the Italian pharmaceutical company Zambon, the European Medicines Agency (EMA) approved the drug. In the following years, the drug has been launched in several European countries. Safinamide is the first antiparkinson medication to be approved for ten years. Safinamide was approved by US FDA in March 2017 for people with Parkinsons taking levodopa/carbidopa during "off" episodes. Research
Potential additional uses might be restless legs syndrome (RLS) and epilepsy. Safinamide was being tested in Phase II trials in 2008, but no results are available. When used as an adjunct to parkinsonian medication, safinamide was found to be efficacious in reducing pain in PD. References
External links
"Safinamide". Drug Information Portal. U.S. National Library of Medicine. "Safinamide mesylate". Drug Information Portal. U.S. National Library of Medicine.