New drugs for schizophrenia! Caprita (lumateprone), an intra cellular therapeutics company, has been approved by the US FDA!

December 24, 2019 / BIOON / -- intra cellular therapeutics (ICT) is a biopharmaceutical company focusing on developing innovative therapies for central nervous system (CNS) diseases Recently, the company announced that the US Food and Drug Administration (FDA) has approved the use of caplyta (lumateprone) for the treatment of adult patients with schizophrenia The company expects to launch to market caplyta by the end of the first quarter of 2020 In terms of medication, the recommended dose of caplyta is 42mg, once a day, taken with food, and dose titration is not required It should be noted that the drug label of caplyta contains a black box warning, which indicates that the risk of death of patients with dementia related psychosis is increased due to the use of antipsychotics; and that caplyta is not approved for the treatment of dementia related psychosis The efficacy of caplyta 42mg was confirmed in two placebo-controlled trials, with a statistically significant difference in the primary endpoint, the total score of the positive and negative symptoms scale (PANSS) The most common adverse reactions (≥ 5% and twice as many as placebo) were drowsiness / sedation (24% vs 10%) and dry mouth (6% vs 2%) when compared with placebo In the summary data of the short-term study, the weight gain, fasting blood glucose, triglycerides and total cholesterol in the caplyta and placebo groups were similar to the average changes at baseline The incidence of extrapyramidal symptoms was 6.7% in the caplyta group and 6.3% in the placebo group Dr Sharon mates, ICT president and CEO, said: "we believe that caplyta will provide a new, safe and effective treatment program for healthcare providers, which will help millions of adult schizophrenics This approval marks the achievements of many years of scientific research We are particularly grateful to patients, their caregivers, and healthcare professionals who have contributed to the development of caplyta " Schizophrenia is a serious mental disease, affecting about 2.4 million adults in the United States The clinical manifestations of schizophrenia are various Acute episodes are characterized by psychiatric symptoms, including hallucinations and delusions, often requiring hospitalization The disease is chronic and lifelong, often accompanied by depression and progressive deterioration of social function and cognitive ability Schizophrenia patients often stop treatment because of side effects such as weight gain and dyskinesia The active component of caplyta is lumateprone, which is a first-in-class small molecule drug It can selectively and simultaneously regulate 5-hydroxytryptamine, dopamine and glutamate, three neurotransmitter pathways involved in serious diseases Lumateperone is a dopamine receptor phosphoprotein modulator (DPPM), which acts as a presynaptic partial agonist and postsynaptic antagonist on D2 receptor This mechanism, together with potential interaction with 5-HT2A receptor, 5-hydroxytryptamine transporter and D1 receptor, and indirect glutamate regulation, may contribute to lumateprone's efficacy across a range of psychiatric symptoms, with improved psychosocial function and good tolerance The compound has the potential to benefit patients with a range of neuropsychiatric disorders and neurodegenerative diseases The molecular structure of lumateprone (source: Wikipedia) in the United States, FDA has granted lumateprone a fast channel status in the treatment of schizophrenia in November 2017 In addition to schizophrenia, ICT is also developing lumateprone for the treatment of other mental disorders, including behavioral disorders in dementia patients, Alzheimer's disease, depression and other neuropsychiatric and neurological disorders In July this year, lumateprone was used as the top line result of two phase III clinical studies (study 401, study 404) on the treatment of bipolar I or bipolar II related major depression with single drug therapy Data showed that in the 404 study, lumateprone 42mg reached the primary end point (P < 0.001) and the secondary end point (P < 0.001) of improving the severity of depression compared with placebo group However, in the 401 study, due to the high clinical response of the placebo group, the two doses of lumateperone (42mg and 28mg) did not reach the primary end point Lumateperone showed good safety and tolerance in two studies Original source: FDA approvals intra cellular therapeutics' new antipsychotics, caplyta ® (lumateprone) for the treatment of schizophrenia in adults