ST LOUIS (MD Consult) - On May 18, 2008, Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, announced that the US Food and Drug Administration (FDA) has approved Risperdal Consta (risperidone) as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. Risperdal Consta is a long-acting antipsychotic drug that originally received FDA approval in 2003 for the treatment of schizophrenia.

This new FDA approval was granted on the basis of results from 2 prospective, randomized, double-blind, placebo-controlled studies for the long-term treatment of bipolar I disorder. Results from the first study demonstrated that Risperdal Consta, when used as a monotherapy, was significantly better than placebo at delaying the time to relapse of any mood episode. Results from the second study demonstrated that for patients already taking lithium or valproate, the addition of Risperdal Consta significantly delayed the time to relapse compared with current treatments plus placebo.

In a clinical study, the most common adverse effects experienced by persons with schizophrenia taking Risperdal Consta were headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, dry mouth, and pain in the extremities. In a study of persons with bipolar I disorder taking Risperdal Consta, the most common adverse events were weight gain (when used alone) and tremors (when used with other medications).

Older patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with patients receiving placebo. Risperdal Consta is not approved for the treatment of patients with dementia-related psychosis.

Risperidone Consta is a long-acting form of risperidone that was developed using technology that allows risperidone to be encapsulated in microspheres made of a biodegradable polymer, which are suspended in a water-based solution. The drug is administered once every 2 weeks by intramuscular injection.

圣路易斯(MD Consult)——2008年5月18日，Ortho-McNeil-Janssen制药公司下属子公司Janssen宣布，美国食品药品管理局(FDA)已批准Risperdal Consta(利培酮)用于双相I型情感障碍的维持治疗。Risperdal Consta可单用或与锂或丙戊酸盐联合使用。Risperdal Consta是一种长效抗精神病药，于2003年首次获FDA批准用于治疗精神分裂症。

该药再获FDA批准，是基于两项应用该药长期治疗双相I型情感障碍的前瞻性、随机、双盲、安慰剂对照研究的结果。第一项研究的结果显示，在延迟任何情感发作的复发时间方面，Risperdal Consta单药治疗显著优于安慰剂。 第二项研究的结果显示，在使用锂或丙戊酸盐的基础上加用Risperdal Consta比加用安慰剂能更显著延迟复发时间。

一项临床研究显示，服用Risperdal Consta精神分裂症患者的最常见不良反应是头痛、帕金森综合征、头晕、静坐不能、疲劳、便秘、消化不良、镇静、体重增加、口干和四肢疼痛。另一项研究显示，服用Risperdal Consta的双相I型情感障碍患者的最常见不良反应是体重增加(单用)和震颤(与其他药物联用)。

服用抗精神病药的痴呆相关精神病老年患者的死亡风险比服用安慰剂的患者的死亡风险更高。Risperdal Consta未获批准用于治疗痴呆相关精神病。

Risperidone Consta是长效型利培酮，为通过先进技术将利培酮包封于生物降解聚合物制成的微球的混悬水溶液。给药方法是每2周肌肉注射1次。