ST LOUIS (MD Consult) - On May 6, 2008, the US Food and Drug Administration (FDA) and Vanda Pharmaceuticals Inc announced the marketing approval of Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia.

Fanapt is a mixed dopamine D2/serotonin 5HT2A receptor antagonist, and belongs to the class of atypical antipsychotics. The labels for all atypical antipsychotics contain a boxed warning that 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. Fanapt is not approved for patients with dementia-related psychosis.

The efficacy of Fanapt for the treatment of schizophrenia was supported by data from 2 short-term clinical trials. Both trials compared Fanapt with placebo and an active control and included patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12 mg to 24 mg per day.

The most common adverse reactions reported by patients using Fanapt in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, drowsiness, tachycardia, and weight gain. Patients receiving Fanapt experienced a low incidence of extrapyramidal symptoms and a placebo-like rate of akathisia, which are adverse events that are often associated with some other drugs in the class of atypical antipsychotics. Similarly to some other drugs in this class, Fanapt may affect heart rhythm parameters and specifically the QTc interval, which may lead physicians to consider prescribing Fanapt after other antipsychotics are tried first.

The recommended target dose range of Fanapt is 12 mg to 24 mg per day. Titration to the target dose of 12 mg per day can be achieved in 4 days. At this time, it is not known how long patients treated with Fanapt should be maintained on treatment. It is generally recommended that responding patients be continued on therapy beyond the acute response. Periodic reassessment should be performed to determine the need for maintenance treatment.

 

圣路易斯(MD Consult)——2008年5月6日，美国食品和药物管理局(FDA)和Vanda制药公司宣布：成人急性精神分裂症治疗药物Fanapt(iloperidone)获批上市销售。

 

Fanapt是一种多巴胺D2/血清素(5-羟色胺2A)双受体拮抗剂，属于非典型性抗精神病药。所有此类药物的说明书上均有加框警告以提醒处方医师，超适应证使用该药治疗老年痴呆性精神病患者的行为问题将导致死亡风险增加。因此，Fanapt在老年痴呆性精神病患者的治疗应用未获批准。

 

2个短期的临床试验数据支持Fanapt具有治疗精神分裂症的作用。2个试验均对Fanapt与安慰剂和阳性对照药做了比较研究，入选患者均符合DSM-III/IV精神分裂症诊断标准。 研究结果证明，每天接受12 mg至24 mg Fanapt的患者，其精神分裂症症状控制方面优于安慰剂。

 

患者接受Fanapt治疗的临床试验中，最常见不良反应有头晕、口干、疲劳、鼻塞、体位性低血压、嗜睡、心动过速以及体重增加。接受Fanapt治疗后，患者的锥体外系症状发病率较低，静坐不能发病率与安慰剂组相似。这两种不良事件往往与其他一些非典型性抗精神病药物相关。与同类的其他药品类似， Fanapt可能会影响心率参数，特别是QTc间期，这可能导致医生开处方时考虑将Fanapt排在其他抗精神病药物之后。

 

Fanapt推荐的靶剂量为每天12毫克到24毫克。开始可在4天内逐渐给药，达到每天12毫克的靶剂量。目前，尚不知患者需维持Fanapt治疗至何时。如无药物急性反应，一般建议应对患者继续进行治疗。应定期评估以确定是否需要维持治疗。