Abstract：
UNASSIGNED: The onset of psychotic symptoms occurs prior to age 19 in 39% of the patients with schizophrenia. There are limited approved treatment options for adolescents with schizophrenia. Brexpiprazole was approved by the United States Food and Drug Administration (FDA) for treatment of schizophrenia in adolescents in 2022.
UNASSIGNED: Extrapolation of adult data to youth and use of pharmacologic modeling coupled with open long-term safety data were used by the FDA to approve brexpiprazole for adolescent schizophrenia. They were all reviewed herein.
UNASSIGNED: D2 receptor partial agonist antipsychotic agents are preferred in the early phase of treatment of psychotic disorders. Approval of brexpiprazole in adolescent schizophrenia provides an additional option. Brexpiprazole was approved by the FDA on the basis of extrapolation of adult data without controlled trials in adolescents. This reduces placebo exposure in young people. Two previous agents (asenapine and ziprasidone) approved for adult schizophrenia failed to separate from placebo in adolescent schizophrenia studies; this partially undermines the process of extrapolation. For brexpiprazole, the paucity of data in adolescents relegates it to a second-line agent. More research on brexpiprazole is needed to delineate its relative role in the management of adolescent schizophrenia.
UNASSIGNED: Extrapolation of adult data to youth and use of pharmacologic modeling coupled with open long-term safety data were used by the FDA to approve brexpiprazole for adolescent schizophrenia. They were all reviewed herein.
UNASSIGNED: D2 receptor partial agonist antipsychotic agents are preferred in the early phase of treatment of psychotic disorders. Approval of brexpiprazole in adolescent schizophrenia provides an additional option. Brexpiprazole was approved by the FDA on the basis of extrapolation of adult data without controlled trials in adolescents. This reduces placebo exposure in young people. Two previous agents (asenapine and ziprasidone) approved for adult schizophrenia failed to separate from placebo in adolescent schizophrenia studies; this partially undermines the process of extrapolation. For brexpiprazole, the paucity of data in adolescents relegates it to a second-line agent. More research on brexpiprazole is needed to delineate its relative role in the management of adolescent schizophrenia.
摘要：
■在39％的精神分裂症患者中，精神病症状的发作发生在19岁之前。青少年精神分裂症的批准治疗选择有限。Brexpiprazole于2022年获得美国食品和药物管理局（FDA）批准用于治疗青少年精神分裂症。
■将成人数据外推至青少年，并使用药物模型结合公开的长期安全性数据，FDA批准了宝立哌唑治疗青少年精神分裂症。这些都在这里进行了综述。
■D2受体部分激动剂抗精神病药物在精神病治疗的早期阶段是优选的。在青少年精神分裂症中批准brexpiprazole提供了另一种选择。Brexpiprazole是FDA根据成人数据外推批准的，没有在青少年中进行对照试验。这减少了年轻人的安慰剂暴露。先前批准用于成人精神分裂症的两种药物（阿塞那平和齐拉西酮）在青少年精神分裂症研究中未能与安慰剂分开；这在一定程度上破坏了外推过程。对于布立哌唑，青少年数据的匮乏使其沦为二线代理。需要更多的研究来描述其在青少年精神分裂症管理中的相对作用。
■将成人数据外推至青少年，并使用药物模型结合公开的长期安全性数据，FDA批准了宝立哌唑治疗青少年精神分裂症。这些都在这里进行了综述。
■D2受体部分激动剂抗精神病药物在精神病治疗的早期阶段是优选的。在青少年精神分裂症中批准brexpiprazole提供了另一种选择。Brexpiprazole是FDA根据成人数据外推批准的，没有在青少年中进行对照试验。这减少了年轻人的安慰剂暴露。先前批准用于成人精神分裂症的两种药物（阿塞那平和齐拉西酮）在青少年精神分裂症研究中未能与安慰剂分开；这在一定程度上破坏了外推过程。对于布立哌唑，青少年数据的匮乏使其沦为二线代理。需要更多的研究来描述其在青少年精神分裂症管理中的相对作用。
