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FDA requests addiction evidence for Newron Parkinson's drug
The FDA has sent a complete response letter to Italian biotech Newron Pharmaceuticals, requesting a clinical evaluation on behaviors relating to abuse liability and dependence/withdrawal effects before its Parkinson’s disease drug can be approved in the United States.
The drug, Xadago (safinamide), was previously rejected by the FDA in 2010. The FDA’s complete response letter represents another delay, as the regulatory body’s Controlled Substance Staff, in the Center for Drug Evaluation and Research, seeks additional evidence.
“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,” Ravi Anand, MD, Newron CMO, said in a press release. “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.”
Xadago has already received marketing approval for the treatment of Parkinson’s disease in the European Union and Switzerland, through Newron’s drug partner Zambon, a pharmaceutical and fine-chemical multinational company based in Italy.
U.S. WorldMeds, a specialty pharmaceutical company based in Kentucky, holds the commercial rights for Xadago in the United States, through a partnership with Zambon.
According to a press release issued by Newron, the biotech and its partners will provide an update on the potential timelines for safinamide’s approval “in the near future.”
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