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    Home > Medical News > Medical World News > FDA Christmas gifts approved four innovative therapies for the benefit of patients

    FDA Christmas gifts approved four innovative therapies for the benefit of patients

    • Last Update: 2019-12-24
    • Source: Internet
    • Author: User
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    With the approaching of Christmas, the FDA in the United States is more "fast forward" in the approval of new drugs Before Christmas, it sent a big gift to many patients On December 20, the FDA approved four innovative therapies in one go, together with today's approval of oral CGRP receptor inhibitors, increasing the number of innovative therapies approved this year to 48 Here are two innovative treatments for insomnia and schizophrenia Around 30% of the world's adults have insomnia symptoms, many of which last for months to years Insomnia is characterized by difficulty in falling asleep or waking up during sleep, although there are plenty of sleep opportunities during the day such as fatigue, inattention and irritability At present, the efficacy of insomnia drugs is not satisfactory, some can help sleep, but can not maintain sustained sleep Moreover, the drugs for insomnia often lead to the situation that the patients are awake and their reaction level drops in the next day, which affects their normal life Dayvigo (lembroexant), developed by Weicai, is an orexin receptor antagonist Orexin, a neuropeptide secreted by hypothalamus, plays an important role in maintaining arousal By blocking the interaction of orexin A and orexin B with orexin receptor 1 (OXR1) and orexin receptor 2 (oxr2), dayvigo can inhibit arousal and treat various symptoms of insomnia Because dayvigo's brain area is more specific than other drugs for insomnia, it has fewer side effects The approval was based on the results of two key phase 3 studies (Sunrise 2 and sunrise 1) that evaluated the efficacy of dayvigo compared with the control and placebo in a total of about 2000 adult insomniacs These results showed that dayvigo showed statistically significant advantages in sleep and sleep maintenance compared with placebo in both subjective and objective evaluation "Dayvigo's approval is very exciting because it is the first approved treatment in a critical clinical trial to report 12-month safety data and improve sleep and sleep maintenance during the six-month trial," Lynn, chief clinical officer, Weicai neurology department "We look forward to providing this innovative treatment option for millions of insomnia patients around the world," Dr Kramer said Schizophrenia is a serious mental illness that affects about 2.4 million adults in the United States The clinical manifestations of schizophrenia are diverse, including hallucinations and delusions, which usually require hospitalization This chronic disease plagues patients for life, usually with depression and progressive deterioration of social function / cognitive ability Patients with schizophrenia often discontinue treatment due to side effects such as weight gain and dyskinesia On December 23, intra cellular therapeutics announced that capleta (lumateprone) has been approved by the US FDA for the treatment of adult schizophrenia Caplyta is a "first in class" strong serotonin 5-HT2A receptor antagonist and a dopamine receptor phosphoprotein modulator (DPPM) It is a partial agonist of presynaptic dopamine D2 receptor and an antagonist of postsynaptic dopamine D2 receptor Based on the activity of dopamine D1 receptor, it can also indirectly regulate the activity of glutamate receptor It is also a serotonin reuptake inhibitor The drug regulates serotonin, dopamine and glutamate neurotransmitter pathways simultaneously It has been awarded fast track qualification by FDA The efficacy of caplyta was confirmed in two placebo-controlled clinical trials, showing a statistically significant improvement in the total score of PANSS compared with placebo "We believe that caplyta provides doctors with a safe and effective new treatment option to help millions of adult patients with schizophrenia," said Dr Sharon mates, CEO and chairman of intra cellular therapeutics We are particularly grateful to the American patient association, their caregivers, and the healthcare professionals who have contributed to the development of caplyta " Original title: express delivery | FDA opens the "Christmas gift" mode! Innovative therapies for insomnia and schizophrenia have been approved successively A kind of
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