New drugs for insomnia! The eludant of ego receptor seroinion, Dayvigo (lemborexant), is on the market in Hong Kong, China!

, July 09, 2020 /
bio-valley smh.com.au/Eisai has announced that a new drug application for its insomnia drug Dayvigo (lemborexant) has been accepted by the Hong Kong Special Administrative Region Of China Health Department to treat insomnia in adults, characterized by difficulty falling asleep and/or maintaining sleepThe application is the first Dayvigo regulatory application to be submitted in Asia outside JapanDayvigo's active drug ingredient is lemborexant, a dual appetite receptor antagonist that inhibits the transmission of appetite nerve signals by competing with two subtypes of appetite receptors (OX1R and OX2R)Appetite is a chemical naturally produced by the hypothalamus that regulates the sleep-wake rhythmBlocking wakefulness promotes the binding effect of the neuropeptide appetite receptor, which is thought to balance the sleep-wake circuit by suppressing excessive wakefulness drivesDayvigo binds to appetite receptors OX1R and OX2R, a competitive antagonist that has a stronger inhibitory effect on OX2RDayvigo provides insomniacs with faster sleep and better sleep maintenanceThe, asmall molecule compound found and developed within Theist,
has been approved by U.Sand Japanese regulators in December 2019 and January 2020, respectively, and will be available in both markets in June and July 2020, respectivelyIn the United States, Dayvigo has 2 size tablets (5mg, 10mg) and in Japan Dayvigo has 3 sizes (2.5mg, 5mg, 10mg)insomnia is a sleep arousal disorder characterized by difficulty falling asleep and/or maintaining sleep despite adequate sleep opportunities, leading to daytime-related consequences such as fatigue, difficulty concentrating and irritabilityInsomnia is one of the most common sleep aydl disorders, with about 30% of adults worldwide having symptoms of insomnia in Hong Kong, China, more than 35% of adults have insomnia symptoms, especially in the elderly, with a higher prevalence rate, and many suffer from insomnia symptoms that last for months to several years As a result, insomnia can cause a variety of social losses, such as long-term absenteeism and reduced productivity, and increase the risk of falls in older people safety is a big problem with sleep drugs Earlier this year, the U.S FDA a black-frame warning for a batch of insomniapills, including Lunesta, Sonata, Ambien, etc., amid reports of deaths and injuries from dangerous activities such as sleepwalking and sleep driving in some patients taking them Dayvigo is a product that solves both sleep problems and sleep maintenance problems, and the mechanism of the drug does not impair morning posture stability and cognitive ability The launch of this product will provide an important new treatment option for the group of insomniacs lemborexant Molecular Structure (Photo: Wikipedia) The Dayvigo Insomnia Clinical Program includes two key Phase III clinical studies of SUNRISE-1 (304 studies) and SUNRISE-2 (303 studies) in a group of approximately 2,000 patients THE SUNRISE-1 STUDY, CONDUCTED IN 1006 PATIENTS AGED 55 YEARS (45% OF PATIENTS AGED 65 YEARS OLD) AND SLEEPLESS AT NIGHT, ASSESSED THE EFFICACY AND SAFETY OF LEMBOREXANT RELATIVE TO PLACEBO AND THE POSITIVE CONTROL DRUG LEOXANOTOL, AND SHOWED THAT THE STUDY REACHED THE PRIMARY AND SECONDARY ENDPOINTS, WITH THE MOST COMMON ADVERSE EVENTS REPORTED BY THE LEMBOREXANT TREATMENT GROUP BEING HEADACHES AND DROWSINESS The SUNRISE-2 study, conducted in 949 adults (18-88 years of age) with insomnia, assessed the efficacy and safety of lemborexant relative to placebo, and the study also reached primary and critical secondary endpoints The most common adverse events reported by the lemborexant treatment group were drowsiness, nasopharyngitis, headache and influenza In addition to these key trials, , Aishi has conducted a number of studies to further evaluate Dayvigo's safety, including studies of lemborexant's ability to awaken sound, the stability of the next day's posture or memory, and its effects on driving performance the next morning The data showed that although there was no significant difference in the ability of lemborexant and placebo to awaken sound, lemborexant had a worsening dose dependence in attention and memory compared to placebo In addition, there was no significant difference between lemborexant and placebo in terms of posture stability or memory on the next day Although the 5 mg and 10 mg doses of lemborexant did not cause statistically significant damage to the driving performance of adults or older subjects the next morning (compared to placebo), driving performance was impaired in some subjects taking a 10 mg dose of lemborexant (BioValleyBioon.com) original source: New Drug Application For In-House Development Ed New Anti-Insomnia Dayvigo DIn Accept Hong