美国FDA批准Nuplazid（pimavanserin 中文名：匹莫范色林）为治疗帕金森氏病伴随幻觉和妄想的第一个药物
FDA的药品评价和研究中心中精神病产品部主任说：“幻觉和妄想可以深刻地令人不安和失能，”。“Nuplazid代表对有帕金森氏病经受这些症状人们的一个重要治疗。” 突破性治疗指定和优先审评
批准日期：2016年4月29日；公司：Acadia制药公司
NUPLAZID™(匹莫范色林 pimavanserin)片，供口服使用
美国初次批准：2016
作用机制
不知道匹莫范色林在伴随帕金森氏病精神病幻觉和妄想的治疗中的作用机制。但是，匹莫范色林的效应可能是通过在5羟色胺5-HT2A受体和至较低程度在5羟色胺5-HT2C受体反相激动剂和拮抗剂活性组合所介导。
适应证和用途
NUPLAZID是一种非典型抗精神病药物适用为伴随帕金森氏病精神病幻觉和妄想的治疗。
剂量和给药方法
⑴推荐剂量是34mg，每天1次口服两17mg片，无滴定调整。
⑵可有或食物服用。
剂型和规格
片：17mg。
禁忌证
无。
警告和注意事项
QT间期延长：在QT间期延长；避免使用药物也增加QT间期和有延长QT间期风险因子患者。
不良反应
最常见不良反应(≥5%和安慰剂率两倍)：周围水肿和混乱状态。
药物相互作用
⑴ 强CYP3A4抑制剂(如，酮康唑[ketoconazole])：减低NUPLAZID剂量一半。
⑵强CYP3A4诱导剂：监视减低疗效。可能需要增加NUPLAZID剂量。
特殊人群中的使用
⑴肾受损：轻度至中度肾受损患者无需对NUPLAZID剂量调整。建议有严重肾受损患者不使用NUPLAZID。
⑵肝受损：建议有肝受损患者不使用NUPLAZID。
如何供应/贮存和处置
NUPLAZID(匹莫范色林)片可得到为:
17mg片: 白色至米白色，圆，包衣片在一侧凹有“P”和在反面凹有“17”。60片瓶：NDC 63090-170-60
贮存：贮存在20°C至25°C(68°F至77°F)；外出允许15°C和30°C间(59°F和86°F) [见USP控制室温]。

NUPLAZID™ (pimavanserin/ACP-103)tablets
IMPORTANT SAFETY INFORMATION AND INDICATION
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs. 2%), nausea (7% vs. 4%), confusional state (6% vs. 3%), hallucination (5% vs. 3%), constipation (4% vs. 3%), and gait disturbance (2% vs. <1%).
Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17 mg tablets once daily, without titration.
INDICATION
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.