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CNS Drugs. 2017 Nov;31(11):1015-1022. doi: 10.1007/s40263-017-0477-1.
Oral lisdexamfetamine dimesylate (Vyvanse; lisdexamfetamine), a prodrug of dextroamfetamine, is currently the only drug to be approved in the USA for the treatment of moderate to severe binge eating disorder (BED) in adult patients. Its approval was based on the results of two pivotal short-term (12 weeks) phase III studies, which showed a significantly greater reduction in binge eating days/week at the end of the study with lisdexamfetamine 50-70 mg/day than with placebo. The findings of these studies have been supported and extended by the results of longer-term (≤ 52 weeks) phase III studies, including one with a randomized 26-week withdrawal phase, which showed that lisdexamfetamine markedly reduced the risk of BED relapse relative to placebo. Lisdexamfetamine was generally well tolerated in clinical trials in patients with moderate to severe BED, with a tolerability profile similar to that observed in ADHD patients; most treatment-emergent adverse events (TEAEs) were of mild or moderate intensity. The most common TEAEs in phase III trials included dry mouth, headache and insomnia; TEAEs infrequently led to study drug discontinuation. In conclusion, lisdexamfetamine 50-70 mg/day is an effective and generally well tolerated option for treating moderate to severe BED in adults.
口服右苯丙胺二甲硫酸盐（Vyvanse；右苯丙胺）是右旋苯丙胺的前体药物，是目前唯一在美国获得批准用于治疗成年患者中重度暴食障碍（BED）的药物。其批准是基于两项关键的短期（12 周）III 期研究结果，这些研究表明，在研究结束时，与安慰剂相比，右苯丙胺 50-70mg/天治疗组每周暴食天数显著减少。这些研究的结果得到了更长时间（≤52 周）III 期研究结果的支持和扩展，包括一项随机 26 周停药期研究，该研究表明，与安慰剂相比，右苯丙胺显著降低了 BED 复发的风险。在中重度 BED 患者的临床试验中，右苯丙胺总体上具有良好的耐受性，其耐受性与 ADHD 患者观察到的相似；大多数治疗中出现的不良事件（TEAEs）为轻度或中度。III 期试验中最常见的 TEAEs 包括口干、头痛和失眠；TEAEs 很少导致研究药物停药。总之，右苯丙胺 50-70mg/天是治疗成人中重度 BED 的一种有效且总体耐受性良好的选择。
