(Source: Economic Daily 2015-01-07）
SyneuRx’s new drug “SND-13”, a psychiatric medication, has been approved by the US FDA as a breakthrough therapy, and is qualified for the priority review and fast-track assessment.
“Breakthrough therapy” is a prestigious status for innovative new drugs. It will increase the chance of receiving marketing approval. The pharmaceutical industry in Taiwan considers whoever wins this status the pride of the nation because it means the product is the first pioneer in its field.
The US FDA considers “SND-13” has the potential to be the next generation treatment for Schizophrenia in adults. Since “SND-13” has also obtained the orphan drug designation, the review process would be faster than standard applications.
The clinical trials on “SND-13” are conducted by Amarex. It expressed that it will work closely with SyneuRx and the US FDA to speed up the launch of “SND-13”.
SyneuRx is one of the few new drug companies in Taiwan focusing on psychiatric treatments. It has eight major product lines, including 3 products in the pre-clinical stage and 5 in the clinical trial stage (3 in Phase II and 2 in Phase II/III). “SND-13” has the best progress so far among all products in the pipeline.
Dr. Emil Tsai, the founder of SyneuRx, explained that the reason for the “breakthrough therapy” status for “SND-13” is that this new product has the potential to completely cure Schizophrenia. If everything goes as expected, “SND-13” may become the best therapy for Schizophrenia.
(Translated by TRPMA)
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