FDA批准每月1次Abilify Maintena治疗精神分裂症

圣路易斯(MD Consult)——2013年3月1日，大冢制药公司宣布美国食品药品管理局(FDA)已批准Abilify Maintena(阿立哌唑)用于治疗精神分裂症。Abilify Maintena是一种每月肌内注射1次的缓释多巴胺D2受体部分激动剂。

《临床精神病学杂志》(Journal of Clinical Psychiatry)2012年5月刊上发表的一项为期52周的安慰剂对照、双盲、随机撤药、3期维持研究证实了Abilify Maintena在精神分裂症患者中的疗效。在该研究中，Abilify Maintena组患者的至复发时间(主要终点)明显长于安慰剂组。研究结束时，Abilify Maintena组出现复发的患者比例(关键次要终点)也显著低于安慰剂组(10% vs. 40%；P<0.0001)。

多项临床试验在1,287例成人精神分裂症患者中评估了Abilify Maintena 300~400 mg剂量的安全性，Abilify Maintena暴露量约为1,281例患者-年。共832例患者接受Abilify Maintena治疗至少180天(至少连续注射7次)，630例接受Abilify Maintena治疗至少1年(至少连续注射13次)。Abilify Maintena的安全性预期与口服阿立哌唑相同，最常见的不良反应为静坐不能。口服阿立哌唑和单盲Abilify Maintena治疗后显示良好耐受且有疗效的患者随后随机接受双盲Abilify Maintena或安慰剂注射，结果显示两个治疗组的不良反应发生率相似。

Abilify Maintena目前尚未被批准用于治疗痴呆相关精神病，并且禁用于已知对阿立哌唑过敏的患者。不良反应包括瘙痒/荨麻疹和过敏等。药品标签的黑框警告称，接受抗精神病药物治疗的老年痴呆相关精神病患者发生死亡的风险增加。

药品标签上的警告和注意事项还提醒注意脑血管事件和卒中、抗精神病药综合征、迟发性运动障碍、代谢紊乱包括高血糖和血脂异常，以及体重增加。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On March 1, 2013, Otsuka announced that the US Food and Drug Administration (FDA) has approved Abilify Maintena (ariprazole) for the treatment of schizophrenia. Abilify Maintena is a dopamine D2 partial agonist in an extended-release formulation that is administered once monthly by intramuscular injection.

Efficacy was demonstrated in a 52-week, placebo controlled, double-blind, randomized-withdrawal, phase 3 maintenance trial of Abilify Maintena in patients with schizophrenia. The time to relapse was the primary end point. In the trial, patients who received Abilify Maintena experienced significant delay in time to relapse compared with patients who received placebo. In a key secondary end point, the percentage of patients experiencing relapse was also significantly lower in patients who received Abilify Maintena versus placebo at the end of the study (10% vs 40%, repectively; P < .0001). Results from the clinical trial of Abilify Maintena were published in the May 2012 issue of the Journal of Clinical Psychiatry. (abstract)

Treatment with Abilify Maintena at a 300- to 400-mg dose has been evaluated for safety in 1,287 adult patients in clinical trials in schizophrenia, with approximately 1,281 patient-years of exposure to Abilify Maintena. A total of 832 patients were treated with Abilify Maintena for at least 180 days (at least 7 consecutive injections) and 630 patients treated with Abilify Maintena underwent at least 1 year of exposure (at least 13 consecutive injections). The safety profile of Abilify Maintena is expected to be similar to that of oral aripiprazole, with the most commonly seen adverse reaction being akathisia. In patients who tolerated and responded to treatment with oral aripiprazole and single-blind Abilify Maintena and were then randomly assigned to receive Abilify Maintena or placebo injections under double-blind conditions, the incidence of adverse reactions was similar between the 2 treatment groups.

Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis, and is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis. A Boxed Warning in the product label warns that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death.

The product label also contains a host of warnings and precautions including cerebrovascular events and stroke, neuroleptic syndrome, tardive dyskinesia, metabolic disturances including hyperglycemia and dyslipidemia, and weight gain.

---------------------------------------------------------------------------------------------------------------------------------------------
欢迎关注Elseviermed官方微信