美国食品和药物管理局批准每月注射的瑞斯佩里用于治疗双相I型精神障碍, 改善了治疗效果和预防复发. FDA approves monthly injectable risperidone for bipolar I disorder, offering improved adherence and relapse prevention.

美国食品和药物管理局批准了UZEDY (RISPERIDONE) 延长释放注射悬浮剂,每月一次用于双相I型精神障碍的成年人,这是首个长效的RISPERIDONE注射. The FDA has approved UZEDY (risperidone) extended-release injectable suspension for once-monthly subcutaneous use in adults with bipolar I disorder, marking the first subcutaneous, long-acting risperidone formulation. 以现有临床数据和模型知情发展为基础,这项批准扩大了UZEDY的使用范围,将其扩大到精神分裂症以外,并提供三种剂量选择(50毫克、75毫克和100毫克),以提高治疗坚持率和减少复发风险。 The approval, based on existing clinical data and model-informed development, expands UZEDY’s use beyond schizophrenia and offers three dosing options—50 mg, 75 mg, and 100 mg—to improve treatment adherence and reduce relapse risk. 该药物使用医疗细胞稳定的TeqTM技术,在6至24小时内达到治疗性血液水平。 The drug, using Medincell’s SteadyTeq™ technology, achieves therapeutic blood levels within 6–24 hours. 常见副作用包括头痛、帕金森病、头晕和体重增加。 Common side effects include headache, parkinsonism, dizziness, and weight gain. 这一举措被视为在两极一型疾病管理中解决未满足需求的一个重大步骤。 The move is seen as a significant step in addressing unmet needs in bipolar I disorder management.