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The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile

sNDA的提交基于研究501和502的积极结果，证明了CAPLYTA强大的抗抑郁疗效以及良好的安全性和耐受性

CAPLYTA, if approved as an adjunctive therapy in MDD, would be indicated for the treatment of three different major psychiatry indications affecting over 30 million adult patients in the US

CAPLYTA如果被批准作为MDD的辅助疗法，将被用于治疗影响美国3000多万成年患者的三种不同的主要精神病学适应症

BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S.

新泽西州贝明斯特（BEDMINSTER），2024年12月3日（Global NEWSWIRE）--专注于中枢神经系统（CNS）疾病治疗药物开发和商业化的生物制药公司Intra Cellular Therapes，Inc.（纳斯达克：ITCI）宣布，它最近向美国提交了补充新药申请（sNDA）。S。

Food and Drug Administration (FDA) for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants..

。。

“MDD is a highly prevalent condition with a significant need for efficacious, safe, and well-tolerated medicines, as more than half of patients do not adequately respond to an antidepressant alone,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies.

“MDD是一种非常普遍的疾病，非常需要有效，安全且耐受性良好的药物，因为超过一半的患者对单独的抗抑郁药没有足够的反应，”细胞内治疗执行副总裁兼首席医疗官Suresh Durgam博士说。

“Given CAPLYTA’s efficacy and safety profile, we believe CAPLYTA can become a first-choice treatment for the adjunctive treatment of MDD pending FDA approval, and we look forward to working with the FDA during this review process.”.

“鉴于CAPLYTA的疗效和安全性，我们相信CAPLYTA可以成为FDA批准之前MDD辅助治疗的首选治疗方法，我们期待在审查过程中与FDA合作。”。

Studies 501 and 502 are two positive Phase 3 global, double-blind, placebo-controlled studies in patients with a primary diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who have had an inadequate response to ongoing anti-depressant therapy.

根据《精神障碍诊断和统计手册》第五版（DSM-5）标准，研究501和502是两项阳性的3期全球双盲安慰剂对照研究，主要诊断为MDD的患者对正在进行的抗抑郁治疗反应不足。

These studies form the basis of the sNDA..

这些研究构成了sNDA的基础。。

CAPLYTA, added to an antidepressant, demonstrated robust efficacy for the treatment of MDD in the primary endpoint, the Montgomery Asberg Depression Rating Scale (MADRS) total score, with a large separation versus placebo of 4.9 points (effect size 0.61) in Study 501 and 4.5 points (effect size 0.56) versus placebo in Study 502..

添加到抗抑郁药中的CAPLYTA在主要终点蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分中显示出治疗MDD的强大疗效，与安慰剂相比，研究501中的4.9分（效应大小0.61）和研究502中的4.5分（效应大小0.56）与安慰剂相比有较大的差异。。

CAPLYTA’s efficacy is complemented with a favorable safety and tolerability profile - including a favorable metabolic, weight and movement disorder profile. In the pooled safety data for Studies 501 and 502, the most commonly reported adverse events that were observed at a rate greater than or equal to 5% for lumateperone and greater than twice the rate of placebo were dizziness, dry mouth, somnolence/sedation, nausea, and fatigue.

CAPLYTA的疗效辅以良好的安全性和耐受性-包括良好的代谢，体重和运动障碍特征。在研究501和502的汇总安全性数据中，最常见的不良事件是头晕，口干，嗜睡/镇静，恶心和疲劳，其发生率大于或等于5%的lumateperone和大于安慰剂的两倍。

Importantly, metabolic and weight changes were similar to placebo and the rates of extrapyramidal symptoms were low..

重要的是，代谢和体重变化与安慰剂相似，锥体外系症状的发生率很低。。

About Major Depressive Disorder

关于重度抑郁症

Major Depressive Disorder (MDD) is a common mood disorder in the U.S. affecting an estimated 21 million adults each year. Depressive disorders are the second cause of years lived with disability in the world. Symptoms include sadness, hopelessness, helplessness, feelings of guilt, irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior.

重度抑郁症（MDD）是美国常见的情绪障碍。S、 估计每年影响2100万成年人。抑郁症是世界上导致多年残疾的第二大原因。症状包括悲伤、绝望、无助、内疚感、易怒、对以前愉快的活动失去兴趣、认知障碍、睡眠模式紊乱以及自杀念头或行为。

MDD can cause severe functional impairment, adversely affecting interpersonal relationships, and may impact quality of life. Approximately two-thirds of patients with depression fail to achieve remission with first-line treatment..

MDD可导致严重的功能障碍，对人际关系产生不利影响，并可能影响生活质量。大约三分之二的抑郁症患者无法通过一线治疗缓解。。

CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

CAPLYTA®（lumateperone）在成人中用于治疗精神分裂症和与双相I或II型障碍（双相抑郁）相关的抑郁发作，作为单一疗法和锂或丙戊酸钠的辅助疗法。

Important Safety Information

重要安全信息

Boxed Warnings:

盒装警告：

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

用抗精神病药物治疗的老年痴呆相关精神病患者死亡风险增加。CAPLYTA未被批准用于治疗痴呆相关精神病患者。

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients..

在短期研究中，抗抑郁药增加了儿科和年轻人自杀念头和行为的风险。应密切监测所有接受抗抑郁药治疗的患者的临床恶化情况，以及自杀念头和行为的出现。CAPLYTA在儿科患者中的安全性和有效性尚未确定。。

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

禁忌症：CAPLYTA禁用于已知对lumateperone或CAPLYTA任何成分过敏的患者。反应包括瘙痒，皮疹（例如过敏性皮炎，丘疹和全身性皮疹）和荨麻疹。

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

警告和注意事项：据报道，抗精神病药物会导致：

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.

老年痴呆相关精神病患者的脑血管不良反应，包括中风和短暂性脑缺血发作。请参阅上面的方框警告。

Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room..

抗精神病药物恶性综合征（NMS），这是一种潜在的致命反应。体征和症状包括：高烧，肌肉僵硬，精神错乱，呼吸，心率和血压变化，肌酐磷酸激酶升高，肌红蛋白尿（和/或横纹肌溶解）和急性肾衰竭。出现NMS体征和症状的患者应立即联系医生或前往急诊室。。

Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.

迟发性运动障碍是面部、舌头或其他身体部位不受控制的身体运动综合征，可能随着治疗时间和总累积剂量的增加而增加。即使CAPLYTA停产，TD也可能不会消失。CAPLYTA停药后也可能发生。

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment..

。据报道，接受抗精神病药物治疗的患者出现了高血糖症，在某些情况下是极端的，并伴有酮症酸中毒，高渗性昏迷或死亡。在开始CAPLYTA时测量体重并评估空腹血糖和血脂，并在长期治疗期间定期监测。。

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors..

白细胞减少症，中性粒细胞减少症和粒细胞缺乏症（包括致命病例）。对于已有低白细胞计数（WBC）或白细胞减少或中性粒细胞减少病史的患者，应进行全血细胞计数。如果在没有其他致病因素的情况下发生临床上显着的白细胞下降，则应停止CAPLYTA。。

Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease.

血压下降和头晕。当患者从坐姿或卧位（体位性低血压）上升过快时，可能会感到头晕，头晕或昏厥。应监测心率和血压，并警告患者患有已知的心脑血管疾病。

Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension..

对于易患低血压的患者，应监测体位生命体征。。

Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.

跌倒。CAPLYTA可能会引起嗜睡或头晕，并会减慢思维和运动技能，从而可能导致跌倒，从而导致骨折和其他伤害。使用CAPLYTA时应评估患者的风险。

Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

癫痫发作。对于有癫痫病史或癫痫发作阈值较低的患者，应谨慎使用CAPLYTA。

Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.

认知和运动障碍的可能性。患者在操作机器或机动车辆时应谨慎，直到他们知道CAPLYTA对他们的影响。

Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.

体温失调。CAPLYTA应谨慎用于可能会增加核心体温的患者，例如剧烈运动，酷热，脱水或伴随抗胆碱能药物。

Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

吞咽困难。对于有误吸风险的患者，应谨慎使用CAPLYTA。

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.

药物相互作用：CAPLYTA不应与CYP3A4诱导剂一起使用。建议与强CYP3A4抑制剂或中度CYP3A4抑制剂同时使用减少剂量。

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

特殊人群：妊娠晚期接触抗精神病药物的新生儿在分娩后有锥体外系和/或戒断症状的风险。对于中度或重度肝功能损害的患者，建议减少剂量。

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

不良反应：CAPLYTA与安慰剂临床试验中最常见的不良反应是嗜睡/镇静，头晕，恶心和口干。CAPLYTA有10.5毫克，21毫克和42毫克的胶囊。

Please click here to see full Prescribing Information including Boxed Warning.

请单击此处查看完整的处方信息，包括盒装警告。

About CAPLYTA (lumateperone)

关于凯利达（lumateperone）

CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors..

CAPLYTA 42 mg是一种口服，每日一次的非典型抗精神病药物，在成人中被批准用于治疗精神分裂症和与双相I或II型障碍（双相抑郁）相关的抑郁发作，作为单一疗法和锂或丙戊酸钠的辅助疗法。虽然CAPLYTA的作用机制尚不清楚，但CAPLYTA的功效可以通过中枢5-羟色胺5-HT2A受体的拮抗剂活性和中枢多巴胺D2受体的突触后拮抗剂活性的组合来介导。。

Lumateperone is being studied for the treatment of major depressive disorder, and other psychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.

Lumateperone正在研究用于治疗重度抑郁症以及其他精神和神经疾病。Lumateperone未经FDA批准用于这些疾病。

About Intra-Cellular Therapies

关于细胞内疗法

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.

Intra Cellular Therapeutics是一家基于诺贝尔奖获得者研究的生物制药公司，该研究使我们能够了解治疗如何影响体内细胞的内部工作。该公司利用这种细胞内方法为患有复杂精神病和神经系统疾病的人开发创新疗法。

For more information, please visit www.intracellulartherapies.com..

有关更多信息，请访问www.intracellulartherapies.com。。

Forward-Looking Statements

前瞻性声明

This news release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”，这些声明涉及风险和不确定性，可能导致实际结果与历史结果或此类前瞻性声明明示或暗示的任何未来结果产生重大差异。

Such forward-looking statements include statements regarding, among other things, the potential approval of CAPLYTA (lumateperone) for the treatment of major depressive disorder as adjunctive therapy, our expectations regarding the commercialization of CAPLYTA; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability or reporting of results; plans to make regulatory submissions to the FDA and the timing of such submissions and any product approvals; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements.

这些前瞻性声明包括关于CAPLYTA（lumateperone）作为辅助疗法治疗重度抑郁症的潜在批准的声明，我们对CAPLYTA商业化的期望；我们计划进行临床或非临床试验，以及这些试验的发展时间，包括临床行为的登记、开始或完成，或结果的可用性或报告；计划向FDA提交监管文件，以及提交时间和任何产品批准；临床试验结果是否可以预测未来的现实结果；CAPLYTA是否会满足未满足的需求；我们发展计划的目标；我们对候选产品潜在效用的信念；以及标题为“关于细胞内疗法”的开发工作和计划。所有这些前瞻性陈述都是基于管理层目前的期望，并受到某些因素、风险和不确定性的影响，这些因素、风险和不确定性可能导致实际结果、事件结果、时间安排和表现与这些陈述所表达或暗示的有实质性差异。

These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; whether CAPLYTA receives adequate r.

这些风险和不确定性包括但不限于以下内容：无法保证CAPLYTA在商业上取得成功；在CAPLYTA商业化过程中，我们可能会遇到问题、延误或其他挑战；CAPLYTA是否收到足够的r。

Contact:

联系人：

Intra-Cellular Therapies, Inc.Juan Sanchez, M.D.Vice President, Corporate Communications and Investor Relations646-440-9333

Intra Cellular Therapes，Inc.Juan Sanchez，医学博士，公司传播和投资者关系副总裁646-440-9333

Burns McClellan, Inc.Cameron Radinoviccradinovic@burnsmc.com646-930-4406

Burns McClellan，股份有限公司CameronRadinoviccradinovic@burnsmc.com646-930-4406

Source: Intra-Cellular Therapies, Inc.

来源：细胞内疗法公司。