FDA accepts New Drug Listing Request from Zogenix for Fintepla (ZX008)
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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Dravet syndrome, also known as infant severe myoclonic epilepsy (SMEI), is a rare, refractory epilepsyZogenix(http:// announcedthat the u.SFDA(http://has accepted the company's application fornew drug(http://market (NDA) for Fintepla (ZX008, oral low-dose fluoroamphetamine) to treat seizures associated with Drveta syndromeAbout ZX008ZX008 developed by Zogenix is a low-dose fluoroamphetamine in a liquid formIt can reduce the frequency of seizures by regulating serotonin mechanisms and sigma-1 receptor activityZX008 has been granted orphan drug status in the United States and the European Union, and it has been certified as a breakthrough therapy by the FDAThe application is based on data from two key Phase 3 clinicaltrial (http:// and the results of the interim analysi
s (http:// of an ongoing open label expansion trial The trials included 232 patients and were treated for up to 21 months In one of the key Phase 3 clinical trials, Fintepla had an average 54.7% reduction in the number of spastic seizures per month (p0.001) compared to the placebo group .
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