SyneuRx Receives US FDA Breakthrough Therapy Designation for SND12 for the Treatment of Refractory Schizophrenia in Adults
Dec 19, 2015
Taipei, December 19, 2015- SyneuRx International (Taiwan) Corp., a global biotech company developing novel therapies for the central nervous system disorders, today announced that the US FDA has granted Breakthrough Therapy designation (BTD) for SND12 for the treatment of refractory schizophrenia in adults. This is the second BTD granted to SyneuRx for the treatment of schizophrenia. Patients are considered as refractory if they fail to respond to at least two classes of antipsychotics. And yet, there is a large number of patients, more than 40% of schizophrenia, who are treatment refractory. SND12 is intended to be the last line medication to treat refractory schizophrenia.
To facilitate the execution of clinical trials and avoid the competition of patient recruitment, SyneuRx will conduct multinational, multicenter, phase II/III clinical trials for SND12 in parallel with SND13, hoping to provide these breakthrough therapies to schizophrenia patients and their family as soon as possible.
About SyneuRx International (Taiwan) Corp.
SyneuRx is a global biotech company , undergoing clinical development of new classes of drugs for multiple major CNS disorders. Several early and late phase clinical trials are currently in progress for multiple indications globally, including schizophrenia, dementia, depression.
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