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Neurocrine Biosciences宣布发表3期KINECT®-4事后分析,证明长期使用INGREZZA®(缬那嗪)胶囊对迟发性运动障碍的临床意义和持续改善

Neurocrine Biosciences Announces Publication of Phase 3 KINECT®-4 Post Hoc Analysis Demonstrating Clinically Meaningful and Sustained Improvement in Tardive Dyskinesia With Long-Term Use of INGREZZA® (valbenazine) Capsules

CISION 等信源发布 2024-05-22 04:05

可切换为仅中文


SAN DIEGO, May 21, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the publication of data from a post hoc analysis of the Phase 3 KINECT®-4 study of INGREZZA® (valbenazine) capsules in the Journal of Clinical Psychopharmacology. The analysis assessed long-term outcomes relevant to the real-world management of tardive dyskinesia (TD) and demonstrated that nearly all study participants met the threshold for clinically meaningful improvements in TD symptom severity by Week 48..

圣地亚哥,2024年5月21日/PRNewswire/--Neurocrine Biosciences,Inc.(纳斯达克:NBIX)今天宣布在《临床精神药理学杂志》上公布了INGREZZA®(缬苯那嗪)胶囊3期KINECT®4期研究的事后分析数据。该分析评估了与现实世界中迟发性运动障碍(TD)管理相关的长期结果,并证明几乎所有研究参与者在第48周达到了TD症状严重程度临床意义改善的阈值。。

'TD is a persistent, debilitating disorder requiring continuous treatment to effectively and sustainably improve symptoms over time,' said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. 'This post hoc analysis, along with previous long-term analyses, demonstrate the reliable, long-term efficacy and tolerability of one-capsule, once-daily INGREZZA to help inform use of this treatment in clinical practice.'.

Neurocrine Biosciences首席医学官EiryW.Roberts医学博士说,TD是一种持续性的衰弱性疾病,需要持续治疗才能有效且可持续地改善症状这项事后分析,以及之前的长期分析,证明了一种胶囊的可靠,长期疗效和耐受性,每天一次,有助于在临床实践中使用这种治疗。”。

The KINECT-4 study implemented an open-label design and on-site assessments of TD severity. The analysis included 103 participants from the Phase 3 KINECT-4 study who completed 48 weeks of treatment with INGREZZA. KINECT-4 was designed to be representative of clinical practice to provide insight into real-world management of TD with INGREZZA..

KINECT-4研究实施了开放标签设计和TD严重程度的现场评估。该分析包括来自KINECT-4第3阶段研究的103名参与者,他们用INGREZZA完成了48周的治疗。KINECT-4旨在代表临床实践,以便与INGREZZA一起深入了解TD的现实管理。。

Key highlights include:

主要亮点包括:

At Week 4, 55% of participants experienced clinically meaningful improvement in TD symptom severity on the lowest starting dose (40 mg). A clinically meaningful improvement was defined as a reduction of at least 2 points in the Abnormal Involuntary Movement Scale (AIMS) total score used to assess the severity of involuntary movements in different body regions.

在第4周,55%的参与者在最低起始剂量(40 mg)下经历了TD症状严重程度的临床有意义的改善。临床上有意义的改善被定义为异常不自主运动量表(AIMS)总分减少至少2分,用于评估不同身体部位不自主运动的严重程度。

Ninety-five percent of participants reached this threshold as soon as Week 24, with 97% achieving it by Week 48. TD improvement was sustained throughout treatment, with an AIMS mean total score reduction from baseline to Week 48 of 10.5..

95%的参与者在第24周就达到了这个门槛,97%的参与者在第48周达到了这个门槛。TD在整个治疗过程中持续改善,AIMS平均总分从基线到第48周降低了10.5分。。

Eighty-six percent of participants met the response threshold of at least 50% AIMS improvement, and 52% met the higher threshold of at least 70% AIMS improvement at Week 48.

86%的参与者在第48周达到了AIMS改善至少50%的响应阈值,52%达到了AIMS改善至少70%的更高阈值。

More than 88% of patients and healthcare professionals rated participants' symptoms as 'much improved' or 'very much improved' at Week 48, as measured by the Patient Global Impression of Change and Clinical Global Impression of Change-TD, respectively.

超过88%的患者和医疗保健专业人员在第48周时将参与者的症状评为“大大改善”或“非常改善”,这分别由患者的全球变化印象和临床全球变化印象TD衡量。

Overall, INGREZZA was generally well tolerated. The most common treatment emergent adverse events reported from Weeks 4 to 48 included urinary tract infection (8.5%) and headache (5.2%).

总体而言,英格里扎的耐受性总体良好。从第4周至第48周报告的最常见的治疗紧急不良事件包括尿路感染(8.5%)和头痛(5.2%)。

About the KINECT-4 Phase 3 StudyKINECT®-4 is a Phase 3, open-label study, in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout.

关于KINECT-4 3期研究KINECT®-4是一项开放标签的3期研究,其中163名患有中度至重度TD和潜在精神分裂症,分裂情感障碍或情绪障碍(包括双相情感障碍或重度抑郁症)的参与者接受了48周的开放标签治疗,每天服用一次INGREZZA(40毫克或80毫克胶囊),然后进行四周的冲洗。

Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated..

所有参与者均以40 mg/天的剂量开始给药,并根据有效性和耐受性在第4周升至80 mg/天。不能耐受80毫克剂量的参与者可以将剂量减少到40毫克。如果不耐受新剂量,则停止患者。。

Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated.

参与者在长期治疗期间经历了TD的改善,从基线到第48周的AIMS总分(项目1-7的总和,由现场评估者评估)的平均变化表明,英格瑞扎40毫克/天(-10.2)或80毫克/天(-11.0)。与之前的研究一致,INGREZZA通常耐受性良好。

After Week 4, treatment emergent adverse events (TEAEs) that occurred in ≥ 5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant..

第4周后,所有参与者(联合剂量组)中≥5%发生的治疗紧急不良事件(TEAE)为尿路感染(8.5%)和头痛(5.2%)。与基线相比,精神稳定性,生命体征,心电图参数和实验室测试值的变化通常很小,并且没有临床意义。。

About Tardive Dyskinesia (TD)Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain.

关于迟发性运动障碍(TD)迟发性运动障碍(TD)是一种运动障碍,其特征是面部,躯干和/或其他身体部位的不可控制,异常和重复运动,这可能会对患者产生破坏性和负面影响。这种情况与服用某些有助于控制大脑多巴胺受体的心理健康药物(抗精神病药物)有关。

Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder, and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD.

服用通常用于治疗重性抑郁障碍、躁郁症、精神分裂症和分裂情感障碍等精神疾病的抗精神病药物,以及用于治疗胃肠道疾病的其他处方药(甲氧氯普胺和丙氯拉嗪)与TD有关。

In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the United States..

对于TD患者,这些治疗被认为会导致大脑控制运动的区域产生不规则的多巴胺信号。TD的症状可能很严重,通常是持续性和不可逆的。据估计,TD将影响美国约60万人。。

About INGREZZA® (valbenazine) CapsulesINGREZZA is the only one-capsule, once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD).

关于INGREZZA®(缬苯那嗪)胶囊INGREZZA是美国批准的唯一一种胶囊,每日一次选择性囊泡单胺转运蛋白2(VMAT2)抑制剂。S、 美国食品和药物管理局用于治疗成人迟发性运动障碍和与亨廷顿舞蹈病(HD)相关的舞蹈病。

INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA selectively targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement.

由Neurocrine Biosciences开发的INGREZZA选择性抑制VMAT2,对VMAT1,多巴胺能(包括D2),血清素能,肾上腺素能,组胺能或毒蕈碱受体没有明显的结合亲和力。虽然INGREZZA治疗TD和HD舞蹈病的具体方法尚不完全清楚,但INGREZZA选择性地靶向VMAT2以抑制多巴胺的释放,多巴胺是大脑中有助于控制运动的化学物质。

INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. Additionally, INGREZZA can be taken as one capsule, once daily together with most psychiatric medications such as antipsychotics or antidepressants. INGREZZA dosages approved for use are 40 mg, 60 mg and 80 mg capsules.

英格瑞扎被认为可以减少额外的多巴胺信号传导,从而减少无法控制的运动。此外,英格瑞扎可以作为一粒胶囊服用,每天一次,与大多数精神病药物如抗精神病药或抗抑郁药一起服用。批准使用的INGREZZA剂量为40毫克、60毫克和80毫克胶囊。

INGREZZA is not approved in any other dosage form..

INGREZZA不被批准用于任何其他剂型。。

Important Information

重要信息

Approved UsesINGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:

批准使用INGREZZA®(缬苯那嗪)胶囊或INGREZZA®Spread(缬苯那嗪)胶囊是用于治疗成人以下疾病的处方药:

movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

面部、舌头或其他身体部位无法控制的运动(迟发性运动障碍)。

involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.

亨廷顿舞蹈病的非自愿运动(舞蹈病)。INGREZZA或INGREZZA Spline不能治愈非自愿运动的原因,也不能治疗亨廷顿舞蹈病的其他症状,例如思维或情绪问题。

It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.

目前尚不清楚英格瑞莎或英格瑞莎喷雾剂对儿童是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

VMAT2抑制剂,包括INGREZZA和INGREZZA Sprink,可对亨廷顿舞蹈症患者产生严重的副作用,包括:抑郁症,自杀念头或自杀行为。如果你患有亨廷顿舞蹈症和抑郁症(患有未经治疗的抑郁症或药物控制不佳的抑郁症)或有自杀念头,请在开始服用英格丽萨或英格丽萨喷雾剂之前告诉你的医疗保健提供者。

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself..

密切注意情绪、行为、思想或感觉的任何变化,尤其是突然变化。当INGREZZA或INGREZZA喷洒开始以及剂量改变时,这一点尤为重要。如果你情绪低落,情绪或行为发生异常变化,或者有伤害自己的想法,请立即致电你的医疗保健提供者。。

Do not take INGREZZA or INGREZZA SPRINKLE if you:

如果您:

are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.

对缬苯那嗪或英格瑞扎或英格瑞扎喷雾中的任何成分过敏。

INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:

INGREZZA或INGREZZA Sprink会引起严重的副作用,包括:

Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives).

过敏反应。过敏反应,包括导致突然肿胀(称为血管性水肿)的过敏反应,可能在服用第一剂或多次服用英格瑞莎或英格瑞莎喷雾剂后发生。过敏反应和血管性水肿的体征和症状包括:呼吸困难或呼吸急促,面部,嘴唇,眼睑,舌头或喉咙或皮肤其他部位肿胀,吞咽困难或皮疹,包括皮肤上凸起,发痒的红色区域(荨麻疹)。

Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema..

喉咙肿胀可能危及生命,并可能导致死亡。如果您出现过敏反应和血管性水肿的症状和体征,请停止服用英格丽莎或英格丽莎喷雾剂,并立即前往最近的急诊室。。

Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE..

嗜睡和疲倦可能导致反应时间缓慢(嗜睡和镇静)。在你知道英格瑞莎或英格瑞莎洒水对你的影响之前,不要开车或操作危险的机器。在使用INGREZZA或INGREZZA Sprink治疗期间,饮酒和服用其他药物也可能导致嗜睡。。

Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint..

心律问题(QT延长)。英格利扎或英格利扎喷雾剂可能会导致心律问题,称为QT延长。如果您在使用英格瑞扎或英格瑞扎喷雾剂治疗期间服用某些其他药物,则QT延长的可能性更高。如果您出现QT间期延长的任何体征或症状,包括:心跳快、慢或不规则(心悸)、呼吸急促、头晕或头晕、晕厥或感觉快要晕倒,请立即告知您的医疗保健提供者。。

Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat..

抗精神病药物恶性综合征(NMS)。NMS是一种可能导致死亡的严重疾病。如果你出现这些症状并且没有其他明显原因,请立即致电医疗保健提供者或前往最近的急诊室:高烧、肌肉僵硬、思维问题、脉搏或血压不规则、出汗增加或心跳过快或不均匀。。

Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.

帕金森样症状。症状包括:身体僵硬、流口水、移动或行走困难、保持平衡困难、颤抖或摔倒。

Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

在服用英格丽莎或英格丽莎喷雾剂之前,请告知您的医疗保健提供者您的所有医疗状况,包括您是否患有肝脏或心脏问题,怀孕或计划怀孕,或正在母乳喂养或计划母乳喂养。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects.

告诉你的医疗保健提供者你服用的所有药物,包括处方药和非处方药、维生素和草药补充剂。确保你告诉所有的医疗保健提供者,你正在服用英格丽萨或英格丽萨喷雾剂。服用英格丽萨或英格丽萨撒上某些其他药物可能会导致严重的副作用。

Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days..

如果您服用地高辛或服用或服用过单胺氧化酶抑制剂(MAOI)药物,请特别告知您的医疗保健提供者。如果您在过去14天内服用或停止服用MAOI,则不应服用INGREZZA或INGREZZA Spline。。

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.

INGREZZA或INGREZZA Sprink对迟发性运动障碍患者最常见的副作用是嗜睡和疲倦。

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.

英格丽莎或英格丽莎喷雾剂对亨廷顿舞蹈病患者最常见的副作用包括嗜睡和疲倦,皮肤上发痒的红色区域(荨麻疹),皮疹以及难以入睡或保持睡眠。

These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

这些并不是INGREZZA或INGREZZA Spread可能产生的所有副作用。打电话给你的医生,询问有关副作用的医疗建议。鼓励您向FDA报告处方药的负面副作用。请访问www.fda.gov/MedWatch或致电1-800-fda-1088。

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

剂型和强度:INGREZZA和INGREZZA Sprink有40毫克,60毫克和80毫克胶囊。

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

请参阅完整的处方信息,包括盒装警告和药物指南。

About Neurocrine Biosciences, Inc.Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.

关于Neurocrine Biosciences,Inc.Neurocrine Biosciences是一家领先的以神经科学为重点的生物制药公司,其目的很简单:缓解需求巨大但选择很少的人的痛苦。我们致力于为神经、神经内分泌和神经精神疾病患者发现和开发改变生活的治疗方法。

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

该公司多元化的产品组合包括FDA批准的治疗迟发性运动障碍、与亨廷顿舞蹈病、子宫内膜异位症*和子宫肌瘤*相关的舞蹈病的药物,以及在我们的核心治疗领域的中晚期临床开发中包括多种化合物的强大渠道。

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook.

三十年来,我们将自己独特的见解应用于神经科学以及大脑和身体系统之间的相互联系,以治疗复杂疾病。我们坚持不懈地寻求药物来减轻使人衰弱的疾病和紊乱的负担,因为你值得勇敢的科学。有关更多信息,请访问neurocrine.com,并在LinkedIn、X(以前的Twitter)和Facebook上关注该公司。

(*in collaboration with AbbVie) .

(*与AbbVie合作)。

The NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, KINECT and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc.

NEUROCRINE BIOSCIENCES徽标Lockup,NEUROCRINE,YOU Worth BRAVE SCIENCE,KINECT和INGREZZA是NEUROCRINE BIOSCIENCES,Inc.的注册商标。

Forward-Looking StatementsIn addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the potential benefits to be derived from INGREZZA and the value INGREZZA may bring to patients.

前瞻性声明除了历史事实外,本新闻稿还包含涉及许多风险和不确定性的前瞻性声明。这些声明包括但不限于关于INGREZZA可能带来的潜在益处以及INGREZZA可能给患者带来的价值的声明。

Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects or adverse reactions; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitati.

可能导致实际结果与前瞻性声明中指出的结果存在重大差异的因素包括:与Neurocrine Biosciences的业务和财务相关的风险和不确定性,以及与INGREZZA商业化相关的风险和不确定性;临床试验活动可能无法预测实际结果或后续临床试验结果的风险;INGREZZA可能因第三方的专有权而无法商业化,或产生意外副作用或不良反应的风险;与竞争产品和技术变化相关的风险和不确定性,可能会限制对英格瑞扎的需求;与INGREZZA和我们的候选产品相关的开发和制造活动依赖第三方相关的风险,以及我们管理这些第三方的能力;FDA或其他监管机构可能对我们的产品或候选产品做出不利决定的风险;我们的产品和/或我们的候选产品可能因第三方的专有权或监管权而无法商业化,或产生意外副作用、不良反应或误用事件的风险;与我们产品的潜在仿制药进入者相关的风险;以及公司向证券交易委员会提交的定期报告中描述的其他风险,包括但不限于。

Reference:

参考号:

Correll CU, Citrome L, Singer C, Lindenmayer JP, Zinger C, Liang G, Dunayevich E, Marder SR. Sustained treatment response and global improvements with long-term valbenazine in patients with tardive dyskinesia. J Clin Psychopharmacology. May 20, 2024. doi:10.1097/JCP.0000000000001860

Correll CU,Citrome L,Singer C,Lindenmayer JP,Zinger C,Liang G,Dunayevich E,Marder SR.长期服用缬苯那嗪对迟发性运动障碍患者的持续治疗反应和整体改善。J临床精神药理学。2024年5月20日。doi:10.1097/JCP.0000000000001860

© 2024 Neurocrine Biosciences, Inc. All Rights Reserved.

©2024 Neurocrine Biosciences,Inc.保留所有权利。

SOURCE Neurocrine Biosciences, Inc.

来源Neurocrine Biosciences,Inc。