Setback for Newron’s Parkinson med

March 31, 2016

Newron thought it had the US approval for its Parkinson’s treatment Xadafo (safinamide) in the bag. Now, however, the FDA demands to see clinical evaluation of the abuse potential of the drug, further delaying market access.

Italian CNS and pain therapy specialist Newron Pharmaceuticals announced it had received the complete response letter from the US’ Food and Drug Administration (FDA) for safinamide. The letter requested more data on the potential effect of the drug on abuse and dependence effects. “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, CMO of Newron, pointed out. 

Now, access to the US market is receding into the distance for Newron and its partners Zambon S.p.A., which holds the global marketing rights for Xadago with the exception of Asia. Just two weeks ago, Zambon had announced an agreement with US WorldMeds to commercialise Xadago for the treatment of Parkinson’s disease in the US. “Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalise plans for the additional experiments,” added Anand, with a promise of an update in the near future.  

Xadafo has already been authorised in the EU, and Zambon has begun commercialisation on the European market. 

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