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FDA approves first Parkinson’s treatment in a decade

pharmafile | March 22, 2017 | News story | Research and Development, Sales and Marketing FDA, Parkinson's, Xadago 

The FDA has approved Xadago (safinamide) as a supplementary treatment for Parkinson’s in patients currently taking levodopa/carbidopa and who are also experiencing bouts of ineffectiveness of these medications.

The decision marks the approval of the first new Parkinson’s treatment in a decade and was driven by the findings of two clinical trials incorporating 1,200 participants in total. The trials examined patients using levodopa who were experiencing ‘off’ episodes with increased symptoms including uncontrolled involuntary movement (dyskinesia). When administered with Xadago, patients experienced a statistically significant reduction in symptoms of the illness compared to placebo and levodopa alone, evaluated via a motor function assessment.   

Parkinson’s is a neurological disorder characterised by the death or impairment of brain cells which produce dopamine, leading to an inability for the body to engage in smooth, purposeful movement. The disorder affects over 50,000 people in the US each year, particularly those over 60. As treatments can become less effective as the disease progresses, leading to a rise in frequency of ‘off’ episodes, the availability of new therapies becomes very significant for patients of the disease.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, Deputy Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

Matt Fellows

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