美国食品药品监督管理局已批准centanafadine（商品名Simtriyo）用于治疗注意力缺陷多动障碍，这是首种同时作用于三种脑化学物质的ADHD药物[1]。该药对6岁及以上儿童和成人有效，与现有刺激类ADHD治疗药物不同，后者通常仅作用于多巴胺和去甲肾上腺素两种物质[1]。Centanafadine的独特之处在于它还靶向血清素[1]。
四项大型第三阶段临床试验证实了该药改善ADHD症状的有效性，通常耐受性良好[1]。最常见的副作用包括食欲不振、失眠、口干和头痛[1]。处方信息中包含关于自杀念头和行为的警告[1]。研究表明，Centanafadine可能比利斯德苯丙胺引起更少的失眠、焦虑、口干和食欲不振[1]。
目前，该药尚未获得澳大利亚治疗商品管理局的批准，也未列入澳大利亚的药品福利计划[1]。
Centanafadine, marketed as Simtriyo, has received U.S. approval for treating attention-deficit/hyperactivity disorder (ADHD) in children aged six and older as well as adults [1]. The medication represents a significant shift in pharmacological approach, as it is the first ADHD drug to act on three neurotransmitters—norepinephrine, dopamine, and serotonin—rather than the two targeted by existing stimulant medications [1]. Current ADHD treatments typically focus only on dopamine and norepinephrine [1].
The approval follows four large Phase 3 clinical trials demonstrating that centanafadine effectively improves ADHD symptoms while generally being well-tolerated [1]. The most frequently reported side effects include reduced appetite, insomnia, dry mouth, and headaches [1]. Research indicates that centanafadine may produce fewer cases of insomnia, anxiety, dry mouth, and appetite loss compared to lisdexamfetamine, another common ADHD medication [1]. However, prescribing information includes a warning regarding suicidal thoughts and behaviors [1].
Despite its U.S. approval, centanafadine has not yet been authorized by Australia's Therapeutic Goods Administration or included in the Pharmaceutical Benefits Scheme [1].
