医学试译稿英译中原文-2013年.docVIP

★ INTRODUCTION For the most accurate and current information regarding the efficacy and safety of R092670 paliperidone palmitate , refer to the latest version of the Investigators Brochure for R092670 paliperidone palmitate; Edition 9, February 25, 2009 . Paliperidone palmitate is the prodrug ester of paliperidone, an oral atypical antipsychotic with dopamine type 2 D2 and serotonin 5-hydroxytryptamine [5-HT] type 2A [5HT2A] receptor antagonism characteristic of second-generation antipsychotics. Paliperidone palmitate is formulated as a long-acting intramuscular i.m. injection for administration by a healthcare professional at once-monthly dosing intervals. The once-daily oral formulation of paliperidone, paliperidone ER INVEGA? , was approved by the U.S. FDA in December 2006 for the treatment of schizophrenia, and subsequently, in April 2007, for the stabilization treatment of schizophrenia. Although INVEGA? was first approved in 2006, clinicians have had extensive experience with the parent molecule of paliperidone, risperidone RISPERDAL? , since 1994. RISPERDAL? is approved for the treatment of schizophrenia in adults and adolescents, the treatment of bipolar mania in adults as monotherapy or in combination with lithium or valproate and in children and adolescents as monotherapy , and for irritability associated with autistic disorder in children and adolescents. However, while the efficacy and safety of oral atypical antipsychotics is well-documented, it is increasingly recognized that long-term data is required to support clinical decision-making when considering a change from short-acting oral to long-acting injectable antipsychotics. This lack of data represents a gap in understanding the relative value of the use of antipsychotic LAT for treating schizophrenia. To fill this knowledge gap and meet the medical needs related to adherence and functional preservation in schizophrenia, clinical examinations switching from oral antipsychotic medicati