Fri, Apr 14, 2017 - Page 4 News List

US FDA expedites reviews of SyneuRx treatments: founder

Staff writer, with CNA

Two drugs developed by SyneuRx International (Taiwan) for the treatment of schizophrenia and designated by the US Food and Drug Administration (FDA) as a breakthrough therapy are to undergo late-stage trials this year, company founder and chief executive officer Guochuan Emil Tsai (蔡果荃) said.

SyneuRx, which developed the drugs SND-12 and SND-13, focuses on the treatment of unmet medical needs in Taiwan of central nervous system disorders.

A breakthrough therapy designation by the US agency expedites drug development, allowing it to grant priority reviews to drug candidates if preliminary clinical trials indicate that the therapy might offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases, the FDA said.

SyneuRx has seven groundbreaking central nervous system treatments that are to undergo late-stage trials this year, Tsai said in an interview with Pharmaboardroom.com, which reports on developments in the international pharmaceutical industry.

SND-12 and SND-13 were granted breakthrough therapy designations by the FDA in December 2014 and November 2015 respectively, which is rare in the central nervous system treatment field, Tsai said.

SND-13 received the designation because it has the potential to completely cure schizophrenia, he said.

If everything goes as expected, it might become the best therapy for the disorder, Tsai added.

SyneuRx was founded in New Taipei City in 2013 by Tsai, an internationally renown neuroscientist and brain disorder researcher and a professor at the University of California, Los Angeles’ Department of Psychiatry and Behavioral Sciences.

He received his doctorate from Johns Hopkins University in Maryland.

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