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。

FDA Approves Quillivant XR (Methylphenidate) for ADHD
Drug expected to be available in January 2013 (Oct. 1)

NextWave Pharmaceuticals, based in Cupertino, Calif., announced on October 1 that the FDA has approved Quillivant XR (methylphenidate hydrochloride) extended-release oral suspension for the treatment of attention-deficit hyperactivity disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with this disorder.

The efficacy of Quillivant XR was evaluated in a randomized, double-blind, placebo-controlled, crossover study of 45 children with ADHD. During an open-label dose-optimization period (4 to 6 weeks), the subjects received an initial 20-mg dose of Quillivant XR once daily in the morning. The dose was titrated weekly in 10- or 20-mg increments until an optimal dose or a maximum dose of 60 mg per day was reached. The subjects then received the individually optimized dose of Quillivant XR or placebo during a 2-week double-blind, crossover treatment phase.

At the end of each week, observers evaluated the attention and behavior of the subjects in a laboratory classroom using the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale. Quillivant XR significantly improved ADHD symptoms compared with placebo at the primary endpoint of 4 hours post-dose. In a secondary analysis, the drug showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

ADHD is one of the most common neurobehavioral disorders in the U.S. According to a 2009 report from the Centers for Disease Control and Prevention (CDC), almost one in ten children (9.5%) aged 4 to 17 years in the U.S. have received a diagnosis of ADHD. The condition often lasts into adulthood, with adult ADHD affecting an estimated 4% of Americans. ADHD is characterized by symptoms that include difficulty paying attention,impulsive behaviors, and in some cases hyperactivity.