US FDA calls for additional evaluation of Xadago

30 March 2016

Italian CNS-focused drug developer Newron Pharmaceuticals (SIX: NWRN) and its partners Zambon and US WorldMeds have received a complete response letter from the US Food and Drug Administration relating to their Parkinson’s disease treatment Xadago (safinamide).

The complete response letter requests clinical evaluation of the potential effect of safinamide on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA. News of the CRL saw Newron’s shares plunge more than 25% to 17.60 Swiss francs in Zurich, where the stock is traded.

Ravi Anand, Newron’s chief medical officer, said: “The complete response letter does not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson’s disease. Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalize plans for the additional experiments.”

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