Newron’s Xadago Nets FDA Approval to Treat Parkinson’s Disease as Add-on Therapy

March 23, 2017

The FDA has approved Newron Pharmaceuticals’ Xadago as an add-on therapy to treat Parkinson’s disease with a dopamine promoter when a patient’s medications are not working and symptoms — such as tremor and difficulty walking — have worsened.

The approval is based on two studies that showed patients who took Xadago in combination with a dopamine promoter experienced reduced symptoms, without uncontrolled involuntary movement, compared to those receiving a placebo. The studies also found patients reported better motor functions when using Xadago.

The European Commission granted Xadago marketing authorization to treat Parkinson’s disease with a dopamine promoter in 2015. The drug is a monoamine oxidase-B (MAO-B) inhibitor designed to block an enzyme that breaks down dopamine, which is involved in controlling movement.

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