Alkermes' treatment of schizophrenia reaches common primary endpoint in clinical trial of the drug ALKS 38313
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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schizophrenia, a serious chronic chronic deactivation brain diseaseThe main symptoms of the disease include hallucinations, delusions, depression, emotional retardation, social withdrawal, and mental disordersrecently, Alkermes(http:// announcedthat itsdrug(http://ALKS 3831 (olanzapine/samidorphan) to reach a common primary end point in theof the 3clinicalTrial (http://) known as ENLIGHTEN-2Alkermes plans to file annew drug(http://application (NDA) for the u.SFDA(http://in mid-2019about ALKS 3831
ALKS 3831 is an innovative and atypical antipsychotic candidate drug that is taken orally once a dayIt consists of two ingredients, samidorphan, a new molecular entity that forms a compound formula pill with the already atypical antipsychotic drug olanzapineWeight gain and clinically related metabolic problems are common side effects of atypical antipsychotic drugsALKS 3831 is designed to improve the safety of therapy while providing a powerful anti-schizophrenic effect of otopine, while reducing side effects on weight and metabolismthe study
561 patients were treated with ALKS 3831 or onopine pine in a multi-center, randomized double-blind Phase 3 clinical trial called ENLIGHTEN-2After 6 months of treatment, the average weight gain (4.21%) in the ALKS 3831 group was significantly lower than that of the Aloxone group (6.59%, p.003)at the same time, the proportion of patients with weight gain of more than 10% was 29.8%, almost twice as much as in the ALKS 3831 patient group (17.8%)
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