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    Home > Medical News > Latest Medical News > FDA approved dayvigo (TM) (lemborexant) for the treatment of adult insomnia

    FDA approved dayvigo (TM) (lemborexant) for the treatment of adult insomnia

    • Last Update: 2019-12-30
    • Source: Internet
    • Author: User
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    Weicai Co., Ltd., announced on December 29 that the U.S Food and Drug Administration (FDA) has approved the new drug application for the orexin receptor antagonist dayvigo (TM) (lamborexant), which was found and developed internally Dayvigo is used to treat insomnia, which is manifested in the difficulty of sleep and / or sleep maintenance in adults In the United States, dayvigo will be sold on the market in 5mg and 10mg tablets according to the plan of DEA, and it is expected to be on the market in 90 days The role of lemborexant in the treatment of insomnia, which is characterized by difficulty in falling asleep and / or maintaining sleep, is achieved through the antagonism of orexin receptor The orexin neuropeptide signaling system plays a role in arousal The combination of orexin A and orexin B with orexin receptors ox1r and ox2r, which promote arousal, was blocked to inhibit the arousal drive Lamborexant binds to orexin receptors ox1r and ox2r As a competitive antagonist, it has a strong inhibitory effect on ox2r * Russell Rosenberg, PhD, d.absm, former chairman of the National Sleep Foundation, the main researcher of dayvigo clinical research, said: "insomnia is a chronic disease, which will have various potential negative effects and long-term consequences on health and happiness." the evidence provided by clinical trials shows that dayvigo can improve the ability of patients to sleep and maintain sleep " Lynn Kramer, MD, chief clinical officer of Weicai neurology business group, said: "we think the approval of dayvigo is particularly exciting because it is the first sleep and sleep maintenance drug approved by the U.S Food and drug administration, and a key clinical study has reported 12-month safety data and 6-month sleep and sleep maintenance efficacy data of the drug We look forward to providing this new treatment option for millions of insomniacs " Weicai has submitted a new drug application for approval for insomnia treatment in Japan (March 2019) and Canada (August 2019) Insomnia is characterized by difficulty in falling asleep, maintaining a state of sleep, or both, despite adequate sleep opportunities, which may affect daytime conditions, such as fatigue, difficulty concentrating, and irritability Insomnia is one of the most common sleep wakefulness disorders, and the incidence rate is high Around 30% of the world's adults suffer from insomnia, many of them for months to years As a result, insomnia can lead to a variety of social losses, such as long-term absences and reduced productivity With dayvigo and R & D efforts focused on orexin biology, Weicai is eager to improve the life of patients with sleep disorders *Lamborexant binds to orexin receptors ox1r and ox2r and acts as a competitive antagonist (IC50 values of 6.1nm and 2.6nm, respectively) After activation, ox1r can inhibit REM sleep, and ox2r can inhibit non REM sleep and REM sleep Lemborexant achieves sleep by preventing the activation of ox1r and ox2r Source: Weicai (China) Pharmaceutical Co., Ltd (original deleted) Mengmeng
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