Bozzatello Paola, Novelli Roberta, Schisano Rebecca, Brasso Claudio, Rocca Paola, Bellino Silvio
Department of Neuroscience, University of Turin, Via Cherasco 15, 10126 Turin, Italy.
Pharmaceuticals (Basel). 2025 Apr 30;18(5):665. doi: 10.3390/ph18050665.
Psychiatric disorders are a major cause of illness in the world. Unfortunately, many patients are resistant to treatment and present serious complications. Schizophrenia is refractory to treatment in about one-third of patients. Antidepressants are effective in about half of patients. Suicidal ideation is an increasing issue in patients with mixed features in bipolar disorder (BD). Therefore, there is a need to develop and test new drugs or new indications of available medications for the treatment of psychiatric disorders through evidence-based investigations. This narrative review aims to present the molecules approved by the main drug agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), from 2018 to date, along with new indications and new formulations of existing medications. We searched PubMed for new drugs approved for schizophrenia, BD, major depressive disorder (MDD), anxiety disorders, and obsessive-compulsive disorder (OCD). We evaluated their clinical benefits, safety, and tolerability profiles. Finally, we considered studies on the main molecules that have shown initial evidence of efficacy and are in the process of obtaining approval. Our search suggested that a new antipsychotic, lumateperone, and two drug combinations, olanzapine/samidorphan (OLZ/SAM) and xanomeline/trospium (KarXT), were approved for schizophrenia. In addition, some new methods of administration-monthly risperidone administration, subcutaneous risperidone administration, and transdermal asenapine administration-obtained approval from the main drug agencies. Lumateperone and OLZ/SAM were also approved in BD. Esketamine, a compound that modulates glutamatergic transmission, was approved to treat treatment-resistant depression and acute suicidal ideation. The dextromethorphan/bupropion combination was approved for MDD. Two new agents, brexanolone and zuranolone, were approved for treatment of postpartum depression. On the other hand, no new drugs received approval for anxiety disorders or OCD. In summary, some new psychotropic medications have been developed, in particular with the aim to improve the symptoms of resistant patients and to decrease the incidence of adverse effects. It is necessary to continue testing the effectiveness of new compounds in methodologically rigorous studies.
精神疾病是全球主要的致病原因。不幸的是，许多患者对治疗有抵抗性并出现严重并发症。约三分之一的精神分裂症患者对治疗难治。约一半的患者服用抗抑郁药有效。双相情感障碍（BD）中具有混合特征的患者自杀观念问题日益严重。因此，有必要通过循证研究来研发和测试用于治疗精神疾病的新药或现有药物的新适应症。本叙述性综述旨在介绍自2018年至今主要药物监管机构，即美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准的分子，以及现有药物的新适应症和新剂型。我们在PubMed上搜索了获批用于精神分裂症、双相情感障碍、重度抑郁症（MDD）、焦虑症和强迫症（OCD）的新药。我们评估了它们的临床益处、安全性和耐受性。最后，我们考虑了对已显示初步疗效证据且正在审批过程中的主要分子的研究。我们的搜索表明，一种新型抗精神病药物鲁马哌酮以及两种药物组合，即奥氮平/沙美阿片（OLZ/SAM）和 xanomeline/曲司氯铵（KarXT）获批用于治疗精神分裂症。此外，一些新的给药方法——利培酮每月给药、皮下注射利培酮和阿立哌唑透皮给药——获得了主要药物监管机构的批准。鲁马哌酮和OLZ/SAM也获批用于双相情感障碍。艾氯胺酮，一种调节谷氨酸能传递的化合物，获批用于治疗难治性抑郁症和急性自杀观念。右美沙芬/安非他酮组合获批用于重度抑郁症。两种新药，布雷沙诺龙和祖拉诺龙，获批用于治疗产后抑郁症。另一方面，没有新药获批用于焦虑症或强迫症。总之，已经研发出一些新型精神药物，特别是旨在改善难治性患者症状并降低不良反应发生率。有必要在方法学严谨的研究中继续测试新化合物的有效性。
