Tadros Emile, Keerthana Shirley, Padder Samar, Totlani Jayant, Hirsch Drew, Kaidbay Daniel N, Contreras Lorena, Naqvi Aasim, Miles Samuel, Mercado Krista, Meyer Ashley, Renteria Sabrina, Pechnick Robert N, Danovitch Itai, IsHak Waguih William
Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Corewell Health East, Dearborn, MI, USA.
Drugs Context. 2025 Apr 3;14. doi: 10.7573/dic.2024-11-2. eCollection 2025.
This systematic review examines psychiatric medications approved by the FDA for anxiety disorders, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD) from 2008 to 2024 and describes the mechanism of action, indications for both labelled and off-label uses, evidence for efficacy, dosing and adverse effects for each medication.
The methodology involved a literature search of the PubMed database for studies published from 1 January 2008 to 31 December 2024 on FDA-approved psychiatric medications and phase III pipeline medications, using the keywords: "anxiety" OR "PTSD" OR "OCD" AND "psychopharm*" OR "medic*" OR "pharm*". The authors conducted independent assessments of the resulting articles and reached a consensus on eligible studies to include in this systematic review.
Our review revealed that, in the past 16 years, the FDA approved only two medications for anxiety disorders (a delayed-release form of duloxetine for generalized anxiety disorder and an extended-release form of lorazepam) and none for PTSD or OCD. We also identified 14 pipeline medications for anxiety disorders, eight for PTSD and one for OCD, all of which are currently in phase III clinical trials.
Our results showed a paucity of new medications for anxiety disorders and none for PTSD and OCD in the past 16 years. However, phase III psychiatric medications for anxiety disorders, PTSD and OCD seem to show several agents with novel mechanisms of action, various modes of administration, and improved side-effect profiles.
本系统评价考察了2008年至2024年期间美国食品药品监督管理局(FDA)批准用于治疗焦虑症、创伤后应激障碍(PTSD)和强迫症(OCD)的精神科药物,并描述了每种药物的作用机制、标签注明用途和未标明用途的适应症、疗效证据、给药剂量及不良反应。
该方法包括在PubMed数据库中进行文献检索,以查找2008年1月1日至2024年12月31日发表的关于FDA批准的精神科药物和III期在研药物的研究,使用的关键词为:“焦虑症”或“创伤后应激障碍”或“强迫症”以及“精神药理学*”或“药物*”或“药理学*”。作者对所得文章进行独立评估,并就纳入本系统评价的合格研究达成共识。
我们的评价显示,在过去16年中,FDA仅批准了两种用于治疗焦虑症的药物(度洛西汀缓释剂型用于广泛性焦虑症和劳拉西泮缓释剂型),而未批准用于治疗创伤后应激障碍或强迫症的药物。我们还确定了14种用于治疗焦虑症的在研药物、8种用于治疗创伤后应激障碍的在研药物和1种用于治疗强迫症的在研药物,所有这些药物目前均处于III期临床试验阶段。
我们的结果表明,在过去16年中,用于治疗焦虑症的新药匮乏,而用于治疗创伤后应激障碍和强迫症的新药则不存在。然而,用于治疗焦虑症、创伤后应激障碍和强迫症的III期精神科药物似乎显示出几种具有新作用机制、多种给药方式和改善副作用谱的药物。