FDA Christmas Gift Approves 4 Innovative Treatments for Patients

The approved market for Theosin receptor antagonist Dayvigoabout 30 percent of adults worldwide have insomnia symptoms, many of which can last for months to yearsInsomnia disorders are characterized by difficulty falling asleep, or waking up mid-sleep, although there is ample opportunity to sleep during the day with symptoms such as fatigue, inattention and irritabilityCurrent treatment of insomnia drugs is not satisfactory, some can help sleep, but can not maintain continuous sleepMoreover, medications for insomnia often have conditions that cause patients to become awake and have decreased levels of response during the day, affecting their normal lives's lembroexant is an appetite inn receptor antagonistAppetite is a neuropeptide secreted by the hypothalamus that plays an important role in maintaining arousalBy blocking the combination of appetite hormone A and appetite B with appetite receptor 1 (OXR1) and appetite hormone receptor 2 (OXR2), Dayvigo can suppress awakening and thus treat a variety of symptoms of insomniaBecause Dayvigo acts on a brain region that is more specific than other drugs for insomnia, it has fewer side effectsimage source: The National Sleep Foundation websitethis approval is based on the results of two key three-phase studies (SUNRISE 2 and SUNRISE 1) that assessed Dayvigo's efficacy compared to controlled drugs and placebos in a total of about 2,000 adult insomnia patientsThese results showed that Dayvigo showed a statistically significant advantage in sleep and sleep maintenance compared to placebos in both subjective and objective evaluation"Sdayvigo's approval is very exciting because it is the first 12-month safety data to be reported in a critical clinical trial and an approved treatment for improving sleep and sleep maintenance during a six-month trial," said DrChief clinical officer of Thejournal Neurology Department," said DrChief clinical officer drclinical officer clinical officer clinical officer clinical officer clinical officer clinical officer clinical officer clinical officer clinical of TheosiWith the approval of Intra-Cellular's innovative treatment for schizophrenia
schizophrenia is a serious mental illness affecting about 2.4 million adults in the United States Schizophrenia has a variety of clinical manifestations, including hallucinations and delusions, and usually requires hospitalization This chronic disease plagues patients for life, often accompanied by depression and progressive degradation of social function/cognitive abilities Patients with schizophrenia often interrupt treatment due to side effects such as weight gain and movement disorders December 23, Intra-Thecellularis announced that Caplyta has been approved by the U.S FDA to treat adult schizophrenia Caplyta is a "first-in-class" powerful serotonin 5-HT2A receptor antagonist, and it is a dopamine receptor phosphoprotein regulator (DPPM) It is part of the antagonist of the pre-synaptic dopamine D2 receptor, an antagonist of the post-synaptic dopamine D2 receptor Based on the activity of dopamine D1 receptors it can also indirectly regulate glutamate receptor activity And it's also a serotonin reuptake inhibitor The drug regulates the neurotransmitter pathways of serotonin, dopamine and glutamate at the same time It has been granted fast-track by the FDA The efficacy of Caplyta was demonstrated in two clinical trials with placebo control and showed a statistically significant improvement over placebo in total positive and negative symptom scales (PANSS) "We believe Caplyta provides doctors with a safe and effective new treatment option to help millions of adults with schizophrenia," said Dr Sharon Mates, CEO and Chairman of the Intra-Cellular Therapies We are particularly grateful to the American Patients Association, their caregivers, and the medical professionals who contributed to the development of Caplyta References: U.S FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients Retrieved December 23, 2019, from https:// Retrieved December 23, 2019, from https:// Retrieved December 23, 2019, from® https:// Origind December 23, 2019, from http:// original title: Courier FDA turns on "Christmas Gift" mode! Innovative treatments for insomnia and schizophrenia have been approved