Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
J Atten Disord. 2020 Jan;24(2):348-358. doi: 10.1177/1087054719836159. Epub 2019 Mar 29.
The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( < .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( < .05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite. SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.
本研究旨在评估 SPN-812（盐酸文拉法辛缓释片）治疗 6 至 12 岁儿童 ADHD 的疗效和安全性。在一项为期 8 周的研究中，222 名参与者被随机分配至安慰剂或 SPN-812 100、200、300 或 400mg/天组。评估指标包括 ADHD 评定量表（RS）-IV 总分以及临床总体印象严重程度（CGI-S）和临床总体印象改善（CGI-I）评分。安全性评估包括实验室和心电图（ECG）检查、自杀意念监测（哥伦比亚自杀严重程度量表）以及不良事件（AE）报告。与安慰剂相比，200、300 和 400mg 剂量组的 ADHD-RS-IV 总分显著改善（<0.05；效应量[ES]分别为 0.547、0.596 和 0.623）。300mg 组的 CGI-I 评分和除 100mg 组外所有 SPN-812 组的 CGI-S 评分均显著改善（<0.05）。最常见的不良反应（≥15%）为嗜睡、头痛和食欲减退。SPN-812 可显著减轻 ADHD 症状的严重程度，且具有良好的耐受性。SPN-812 的疗效和安全性正在 III 期临床试验中进行研究。
