英文药名：Ingrezza(valbenazine Capsules) 中文药名：戊苯可宁胶囊 生产厂家：神经生物科学公司 药品简介 每日一次给药为治疗：迟发性运动障碍 美国FDA批准第一个药物治疗迟发性运动障碍[tardive dyskinesia] FDA的药品评价和研究中心内精神产品部主任Mitchell Mathis，M.D.说："迟发性运动障碍可能正在残疾和可能进一步使有精神疾患患者感到羞耻[stigmatize 患者]，"批准首个为迟发性运动障碍治疗的药物对患这种情况患者是一个重要进展。" FDA授权这项申请快速通道，优先审评和突破性治疗指定 批准日期：2017年4月11日；公司：Neurocrine Biosciences，Inc. INGREZZATM(戊苯可宁[valbenazine])胶囊，为口服使用 作用机制 不知道在迟发性运动障碍的治疗中valbenazine的作用机制，但被认为是通过囊泡单胺转运蛋白2(VMAT2)的可逆性抑制作用，一种转运蛋白为贮存和释放调节单胺从胞浆至突触囊泡。 适应证和用途 INGREZZA是一种囊泡单胺转运蛋白2(VMAT2)抑制剂适用为有迟发性运动障碍成年的治疗。 剂量和给药方法 ● 初始剂量是40 mg每天1次。一周后，增加剂量至推荐剂量的80 mg每天1次。 ● 可被有或无食物服用。 ● 对有中度或严重肝受损患者推荐剂量是40mg每天1次。 ●根据耐受性已知CYP2D6差代谢者考虑剂量减低。 剂型和规格 胶囊：40mg. 禁忌证 无。 警告和注意事项 ● 嗜睡：可能损害患者的驾驶或操作危害性机械的能力。 ● QT延长：可能致QT间期延长。有先天性长T 综合证或有心律失常伴随延长QT间期患者避免使用. 不良反应 最常见不良反应(≥5%和安慰剂率两倍): 嗜睡. 药物相互作用 剂量调整由于药物相互作用: 特殊人群中使用 ● 妊娠：可能致胎儿危害。 ● 哺乳：建议不要哺乳喂养。 ●肾受损：有轻度至中度肾受损患者无需剂量调整。建议有严重肾受损患者不使用。 供应/贮存和处置 可得到INGREZZA(valbenazine)胶囊如下： 40 mg胶囊：白色不透明体部有一个紫色帽，用黑墨水印有‘VBZ’和‘40’。 30粒瓶：NDC 70370-1040-1 90粒瓶：NDC 70370-1040-2 贮存 贮存在20°C至25°C(68°F至77°F)；外出允许至15°C至30°C(59°F至86°F)。见USP控制室温。 Neurocrine Announces INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA 11, 2016 U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for INGREZZATM (valbenazine) for the treatment of tardive dyskinesia. The INGREZZA application has been given a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017. "This is another significant milestone for Neurocrine and more importantly those patients who are suffering from tardive dyskinesia," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We will continue to work with the FDA in their review of the INGREZZA NDA to potentially bring this important treatment option to patients and physicians." A Priority Review designation accelerates the FDA review timeline from 10 months to 6 months from the date of acceptance of the NDA. The designation directs the FDA's overall attention and resources to the evaluation of applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of the treatment of a serious condition. INGREZZA (valbenazine) previously received Fast Track status and Breakthrough Designation status from the FDA. The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission. About Tardive Dyskinesia Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips. These symptoms are rarely reversible and there are currently no FDA approved treatments. About INGREZZA VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. INGREZZA (valbenazine or NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters and ion channels. INGREZZA is designed to provide low, sustained, plasma and brain concentrations of active drug to allow for once daily dosing. Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, may provide symptomatic benefits for patients with these diseases. Neurocrine received Breakthrough Therapy Designation from the FDA in 2014 for INGREZZA in the treatment of tardive dyskinesia. The NDA for INGREZZA for the treatment of tardive dyskinesia is currently under Priority Review with the FDA. The proprietary name INGREZZA has been conditionally accepted by the FDA.