FDA Issues Complete Response Letter for Newron’s Parkinson’s Candidate

The FDA issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency.

According to the Italian company, the agency asked for an evaluation of potential abuse, dependence and withdrawal effects related to Xadago.

Ravi Anand, the company’s chief medical officer, said the FDA did not request additional data, studies or analyses of the efficacy of Xadago. He added that his team will meet with the agency’s Controlled Substances Staff and Division of Neurological Projects to determine next steps.