FDA issues complete response letter for safinamide as a treatment forParkinson's disease- Zambon + US World Meds + Newron Pharma

Newron Pharmaceuticals S.p.A. and its partners Zambon S.p.A. and US WorldMeds announced that a complete response letter from the FDA has been received for 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 Food and Drug Administration. Newron commented that the FDA had not called for any new safety or efficacy data, studies or analyses. However an analyst considered that the process could take up to 18 months.

On 17 March 2016 Zambon S.p.A.announced a strategic agreement with US WorldMeds to commercialize Newron’s lead compound, Xadago (safinamide), for the treatment of Parkinson’s disease in the U.S. Zambon S.p.A. holds the global marketing rights for safinamide with the exception of Japan/Asia and has recently begun the commercialization of safinamide under the trade name Xadago in the EU and Switzerland. US WorldMeds plans to focus more than 60 sales representatives launching Xadago in the U.S.

Comment: Marketing authorization in the EU for safinamide was granted by the EU Commission in February 2015, and by Swissmedic in November 2015. Xadago has been launched by Zambon in Germany, Spain and Italy, as well as in Switzerland.