ST LOUIS (MD Consult) - On August 14, 2009, the US Food and Drug Administration (FDA) and Schering-Plough announced the approval of Saphris (asenapine) for the acute treatment of adults with either schizophrenia or with manic or mixed episodes associated with bipolar I disorder, with or without psychotic features. Saphris can be used as a first-line treatment and is classified as an atypical antipsychotic agent.

The FDA approval of Saphris was granted on the basis of data supporting drug efficacy in trials involving more than 3,000 patients with schizophrenia or bipolar mania. Safety data from 4,500 patients, some of whom were treated longer than 2 years, were also considered in the drug's approval. In trials of patients with acute schizophrenia, the efficacy of Saphris (given in doses of 5 mg twice daily) was statistically superior to placebo. In the trials involving patients with acute bipolar I disorder, Saphris (given in doses of 10 mg twice daily) was associated with a statistically significant reduction of bipolar mania symptoms, compared with placebo.

The most common adverse reactions reported by patients in clinical trials being treated for schizophrenia with Saphris were akathisia, oral hypoesthesia, and somnolence. In studies involving patients with bipolar disorder, the most commonly reported adverse events were dizziness, somnolence, weight gain, and movement disorders other than akathisia.

The labels for all atypical antipsychotic medications, including Saphris, contain a boxed warning. This warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older persons with dementia-related psychosis.

圣路易斯（MD Consult）——2009年8月14日，美国食品药物管理局（FDA）和先灵葆雅公司宣布，Saphris已获准作为紧急用药治疗精神分裂症、躁狂症或伴有/不伴有精神病特征表现的I型双向情感障碍。Saphris可用作一线治疗药，属于非典型抗精神病药物。

FDA批准Saphris的依据是一系列临床试验数据，其一为在对精神分裂症或双向躁狂症患者进行的临床试验中获取的支持药物安全性的数据，病例数逾3,000例；另外，在该药的审批内容中还包括由4,500例患者得出的安全性数据，其中有些患者的疗程在2年以上。在对急性精神分裂症患者所做的临床试验中，Saphris的疗效（给药方案：5mg，每日2次）在统计学上显著优于安慰剂对照。此外，在对I型急性双向情感障碍患者进行的临床试验中，与安慰剂对照相比，Saphris（给药方案：10mg，1日2次）亦在统计学上显著减少了双向躁狂症状。

在以Saphris治疗精神分裂症的临床试验中，患者最常报告的不良反应为静坐不能、口腔感觉迟钝以及嗜睡。在对双向情感障碍患者进行的研究中，除了静坐不能外，最常报告的不良事件还有眩晕、嗜睡、体重增加以及运动失调。

Saphris等所有的非典型抗精神病药的说明书中均有一个黑框警告。该警告警示开处方者在患有痴呆相关精神病的老年患者中超适应证使用该药治疗行为问题可能与死亡风险增加有关。

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