2012年10月1日，NextWave 制药公司宣布美国食品药品管理局(FDA)已批准Quillivant XR (盐酸哌甲酯)用于治疗注意力缺陷多动障碍(ADHD)。Quillivant XR是FDA批准的首个用于治疗ADHD的哌甲酯缓释液体制剂，为片剂或胶囊吞服困难患者提供了一种更佳选择。该产品属于中枢神经系统(CNS)兴奋剂，被联邦政府列为管制物品。
Quillivant XR的有效性在一项纳入45例ADHD儿童的随机、双盲、安慰剂对照、交叉、多中心实验室研究中得到了评价。该研究首先为开放的最佳剂量治疗期(4~6周)，患者每天早晨服用1次初始剂量为20 mg的Quillivant XR，每周剂量滴定增加幅度为10或 20 mg，直到达到最佳剂量或每日60 mg最大剂量。然后患者进入2周的双盲、交叉治疗期，接受最佳剂量Quillivant XR或安慰剂治疗。
每周结束时，经过培训的观察者应用Swanson、 Kotkin、Agler、M-Flynn和 Pelham评定量表评估患者注意力和行为。主要终点指标用药后4 小时 ADHD症状改善Quillivant XR组明显优于安慰剂组，用药后45分钟至12小时每个时间点的次要分析也显示显著改善。
基于其他哌甲酯产品的累计数据，应用Quillivant XR最常见的不良反应可能包括食欲下降、恶心、呕吐、消化不良、腹痛、体重下降、焦虑、头晕、烦躁、情绪不稳定、心动过速以及血压升高。
Quillivant XR说明书中包括了一项黑框警告，警告CNS兴奋剂具有滥用和依赖的高度可能性。在开具该药品处方前应评估患者滥用风险，在治疗期间应监测患者滥用和依赖迹象。
Quillivant XR预计在2013年1月上市。
ST LOUIS (MD Consult) - On October 1, 2012, NextWave Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Quillivant XR (methylphenidate hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD). Quillivant XR is the first FDA-approved extended-release liquid formulation of methylphenidate for patients with ADHD, making it a favorable option for patients with difficulty swallowing pills or capsules. The product is classified as a central nervous system (CNS) stimulant and is a federally controlled substance.
The efficacy of Quillivant XR was eva luated in a randomized, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD. The study included an open-label dose optimization period (4-6 weeks) with an initial dose of once daily in the morning. The dose was titrated weekly in 10- or 20-mg increments until an optimal dose or maximum dose of 60 mg per day was reached. Patients then entered a 2-week double-blind, crossover treatment period using the individually optimized dose of Quillivant XR or placebo.
At the end of each week, trained observers eva luated the attention and behavior of the patients in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn and Pelham rating scale. The use of Quillivant XR significantly improved ADHD symptoms compared with placebo at the primary end point of 4 hours post-dose, and in a secondary analysis, showed significant improvement at every time-point measured, from 45 minutes to 12 hours after dosing.
On the basis of accumulated data from other methylphenidate products, the most common adverse reactions that may occur with the use of Quillivant XR include decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure elevation.
The product label for Quillivant XR contains a Boxed Warning that warns that CNS stimulants carry a high potential for abuse and dependence. The risk of abuse should be assessed before prescribing the product, and patients should be monitored for signs of abuse and dependence while on therapy.
Quillivant XR is expected to become available in pharmacies in January 2013. |
