Newron Pharmaceuticals and its partners, Zambon and US WorldMeds, announced that the Food and Drug Administration has issued a Complete Response Letter for Xadago (safinamide) as an adjunctive treatment for Parkinson’s disease (PD).
In the letter, the FDA requested clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence or withdrawal effects as required by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA. No additional studies for Xadago in PD were requested.
Newron intends to meet with the FDA to address the agency’s requests for Xadago. The Company and its partners will provide an update on the potential timeline for approval in the near future.
Safinamide is an oral, once daily, unique molecule with a novel dual mechanism of action. It enhances dopaminergic function through the reversible inhibition of MAO-B and of dopamine uptake and inhibits the excessive release of glutamate.
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