Lurasidone, an atypical antipsychotic, has been approved for treating adults with schizophrenia, the U.S. Food and Drug Administration announced Oct. 28.

The approval of lurasidone was based on the results of four 6-week placebo-controlled studies of almost 1,300 adults with schizophrenia, which found that those treated with lurasidone had a greater response to treatment with lurasidone than did those on placebo, as measured by different scales used to evaluate response to treatment in patients with schizophrenia, according to the drug’s prescribing information.

Lurasidone, which comes in a tablet formulation, will be marketed as Latuda in the United States by Sunovion Pharmaceuticals Inc., It will be available in February 2011, according to the company, which was previously called Sepracor Inc.

A recommended initial dose of 40 mg is recommended; the maximum recommended dose is 80 mg once a day.

In the studies, the most common adverse events associated with treatment were drowsiness, akathisia, nausea, movement abnormalities, and agitation, according to the FDA’s statement announcing the approval. Like other atypical antipsychotics, the label of lurasidone has a boxed warning about the increased risk of death when these drugs are used off label to treat elderly patients with dementia-related psychosis. None of the atypical antipsychotics is approved for that indication.

In the FDA statement, Dr. Thomas Laughren, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, referred to the importance of having multiple treatment options available for treating schizophrenia, because “some patients do not respond well to certain types of drug therapy.��

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

10月28日，FDA宣布非典型抗精神病药物lurasidone获准用于治疗成人精神分裂症。

 

该批准是基于4项有近1,300例成人精神分裂症患者参加的为期6周的安慰剂对照研究。Lurasidone的推荐初始剂量为每天40 mg，其最大推荐剂量为每天80 mg。研究结果表明，评价精神分裂症患者药物反应的不同量表评分均显示，接受lurasidone治疗的患者对药物反应优于安慰剂组患者。

 

使用该药最常见的不良事件为困倦、静坐不能、恶心、运动障碍和烦躁不安。Lurasidone说明书中也有与其他非典型抗精神病药物一样的黑框警告，即若超说明书用于治疗痴呆相关的老年精神病患者可增加其死亡风险。目前尚没有一种非典型抗精神病药物批准用于上述适应证。

 

Lurasidone为片剂，将由Sunovion制药(原Sepracor公司)以商品名Latuda在美国上市，预计上市时间为2011年2月。

 

爱思唯尔  版权所有