FDA approves NEW drug application for JAZZ Pharmaceuticals to repair Xyrem oral solution

seizure sleep disorder is a long-term neurological disease in which patients have reduced their ability to regulate sleep/wake cyclesRecently, the JAZZPharmaceutical s
on announced that the u.SFDA(approved its supplementarynew drug(sNDA) on October 26, 2018, which revised the label of Xyrem (sodium hydroxybutyrate, sodium hydroxbutyrate) oral fluid, added indications, and treated patients 7 years of age with psychosis and excessive sleepinessXyrem
Xyrem, sodium hydroxybutyrate, a central nervous system (CNS) inhibitor that was approved by the U.SFDA in 2002 to treat sepsis, a sudden and transient muscle weakness that is associated with full consciousness, usually triggered by emotions such as laughter and cryingstudiesthe efficacy of Xyrem in treating childhood narcolepsy or EDS is based on a phase 2/3 EXPRESS study, which recruited patients between the ages of 7 and 17 with seizure disordersPatients who took the study will be given Xyrem or placebo control at the beginning of the studycontrol group of the subjects received open marker titration to achieve a tolerable and effective doseAfter a stable dose period, all participants underwent a two-week double-blind randomized withdrawal period and were randomly assigned a stable dose of Xyrem or received a placebothe main therapeutic endpoint of is the change in the number of seizures per week, from the stable dose period (baseline) to the end of the double-blind period From baseline to the end of the double-blind period, assessing EDS changes through the EsS-CHAD diet is a key secondary endpoint indicator After a random suspension period, participants entered the open label for a maximum of 47 weeks, with a total study duration of up to one year the of the trial (results showed that patients who received a placebo at random increased their weekly (median) seizures by 12.7 times per week (median), while patients who continued to be treated with Xyrem increased their seizures by 0.3 times per week (median) (Q1, Q3-1.0; p 0.0001) safety in children and adolescents in this study, and xyremremwas was not found to be safe in children and adolescents after a year of safety part of the open label trial of the study is still ongoing As of February 2017 (data deadline), the most common treatment synopsis (-5%) were urination, nausea, vomiting, headache, weight loss, loss of appetite, nasopharyngitis and dizziness There were two serious sudden adverse events, acute psychosis, severe and suicidal thoughts fda reminds Xyrem that adverse reactions, including seizures, respiratory suppression, decreased levels of consciousness, coma, and death, may occur individually or in combination with other CNS inhibitors 　　The FDA's recommended dose of 0.5g/mL for Xyrem is required to be prescribed in strict accordance with prescriptions, as inappropriate prescriptions, misuse, abuse, and transfer can have serious consequences