佛罗里达州迈阿密市和新泽西州泽西市，2019年10月15日——Hisamitsu Pharmaceutical Co.，Inc.的全资子公司Noven Pharmaceuticals，Inc.今天宣布，美国食品药品监督管理局（FDA）已批准Secuado（阿西那平）透皮系统，第一个也是唯一一个治疗成人精神分裂症的透皮贴剂。1

纽约医学院精神病学和行为科学临床教授Leslie Citrome医学博士说：“随着精神分裂症患者的治疗周期缩短，他们的治疗选择越来越窄，让他们和他们的护理者寻找新的治疗选择。”“除了提供一种新的分娩方式，透皮贴片还可以为看护者和医疗保健提供者提供一种非侵入性的视觉确认，即正在使用治疗。”

每日一次的经皮给药系统（tdds）在服用非典型抗精神病药物阿西那平（一种治疗精神分裂症的有效药物）期间（24小时）提供持续浓度。经皮贴片可能有助于减轻患者在精神分裂症治疗中面临的一些挑战。

诺文制药董事长兼首席执行官Higo博士说：“对新型精神分裂症治疗的需求巨大，诺文致力于为患有这种毁灭性疾病的患者及其家庭成员提供新的选择，帮助他们有效地控制症状，“我们对FDA批准Secuado表示赞赏，并期待它能尽快在美国上市，这样精神分裂症患者就可以选择经皮给药进行阿西那平治疗。”

在第3阶段的国际双盲安慰剂对照研究中，secuado在第6周的总阳性和阴性综合征量表（panss）的变化与安慰剂相比，与基线相比，达到了统计学上显著改善的主要终点。对616例成人精神分裂症患者进行为期6周的疗效和安全性评价。此外，secuado在临床总体印象严重度（cgi-s）评分（第3阶段研究的主要次要终点）方面显示出统计学上的显著改善。

secuado的全身安全性曲线与已知的舌下阿西那平一致。1最常见的不良反应是锥体外系障碍、用药部位反应和体重增加。

什么是secuado？

secuado是一种治疗成人精神分裂症的处方药。secuado是一种用于皮肤的透皮系统（贴片）。尚不清楚塞库阿多对18岁以下的精神分裂症儿童是否安全有效。

重要安全信息

secuado可能引起严重的副作用，包括：

•老年痴呆相关精神病患者死亡风险增加。像secuado这样的药物会增加老年人的死亡风险，他们因为困惑和记忆丧失（痴呆）而失去了与现实（精神病）的联系。塞库阿多不被批准用于治疗痴呆相关精神病患者。

•老年痴呆相关精神病患者中风（脑血管问题），可导致死亡。

•神经肽恶性综合征（NMS）：一种可导致死亡的严重疾病。立即取下补丁。如果您有以下症状，请立即致电您的医疗保健提供者或前往最近的医院急诊室：高烧、精神错乱、肌肉僵硬、出汗增多、呼吸、心率和血压变化。

•不受控制的身体运动（迟发性运动障碍）。secuado可能会引起你无法控制的面部、舌头或其他身体部位的运动。即使你停止服用secuado，迟发性运动障碍也不会消失。迟发性运动障碍也可能开始后，你停止服用secuado。

•新陈代谢问题，如：

o高血糖（高血糖）和糖尿病。一些服用塞库阿多的人血糖会升高。

如果您在使用Secuado治疗期间出现任何高血糖症状，请致电您的医疗保健提供商：

感到非常口渴或非常饥饿

胃部不舒服

感到虚弱或疲倦

需要比平时多排尿

困惑，或者你的呼吸有水果味

o血液中脂肪含量（胆固醇和甘油三酯）增加

o体重增加。您和您的医疗保健提供者应定期检查您的体重，在治疗期间与secuado。

•过敏反应。你可能会出现皮疹、血压下降或心率加快。

•血压降低（直立性低血压）。当你从坐着或躺着的姿势上爬得太快时，你可能会感到头昏眼花或头晕。

•摔倒。secuado可能使你昏昏欲睡或头晕目眩，在换位时可能导致血压下降，并可能减缓你的思维，从而导致摔倒。

•白细胞计数低。您的医疗保健提供者可能会在使用secuado治疗的头几个月进行血液测试。

•不规则心跳或感觉不正常的心跳（qt延长）

•血液中催乳素水平升高（高催乳素血症）。您的医疗保健提供者可能会做血液测试，以检查您的催乳素水平在治疗期间与secuado。

•癫痫发作（抽搐）

•思维和运动技能受损。使用secuado操作重型机械时要小心。

•控制体温的问题，让你感觉太热

•吞咽困难

•外部热量。避免将secuado暴露在直接的外部热源下，如吹风机、加热垫、电热毯、热水床等。

•应用部位反应。如果使用secuado的时间比指示的时间长，或者重复使用同一个应用部位，可能会增加皮肤刺激性。每天使用不同的涂抹部位以减少皮肤反应。如果皮肤反应持续或扩散到应用程序站点之外，请告诉您的医疗保健提供商。应用部位反应的症状可能包括：

o红色

o发痒

o刺激

o丘疹样隆起的皮肤

o皮肤疼痛

o肿胀

如果您：

•对塞库阿平或其他成分过敏。

•严重肝损伤

在您使用secuado之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否已经：

•心脏问题或中风

•低血压或高血压

•糖尿病或高血糖，或有糖尿病或高血糖家族史

•总胆固醇或甘油三酯含量高

•高催乳素水平

•白细胞计数低

•癫痫发作

•肝脏问题

告诉你的医疗保健提供者，如果你怀孕或认为你怀孕期间，与secuado治疗。目前还不知道塞库阿多是否会伤害你的胎儿。

•如果您在接受Secuado治疗期间怀孕，请咨询您的医疗保健提供者，向国家妊娠登记处登记非典型抗精神病药物。您可以通过拨打1-866-961-2388进行注册，或访问https://womensmentalhealth.org/research/pregnancyregistry。

与您的医疗保健提供者讨论在使用secuado治疗期间喂养您的宝宝的最佳方法。现在还不知道secuado是否会进入你的母乳。

告诉您的医疗保健提供者您所服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。secuado和其他药物可能相互影响，造成严重的副作用。secuado可能影响其他药物的工作方式，而其他药物可能影响secuado的工作方式。

secuado最常见的副作用包括：

•躁动、移动困难、肌肉僵硬、震颤

•贴片处的皮肤刺激

•体重增加

告诉你的医疗保健提供者，如果你有任何副作用困扰你或不消失。这些不都是塞库阿多可能产生的副作用。

Secuado (asenapine) Transdermal System

Company: Noven Pharmaceuticals, Inc.
Date of Approval: October 11, 2019
Treatment for: Schizophrenia

Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.

Miami, FL And Jersey City, NJ, October 15, 2019 -- Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced the U.S. Food and Drug Administration (FDA) has approved Secuado (asenapine) transdermal system, the first-and-only transdermal patch formulation for the treatment of adults with schizophrenia.1

“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours)2 of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia. A transdermal patch may help to mitigate some of the challenges patients face with the management of their schizophrenia.2

“There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms,” said Dr. Naruhito Higo, Chairman and Chief Executive Officer, Noven Pharmaceuticals, Inc. “We commend the FDA on the approval of Secuado and look forward to bringing it to market in the U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”

In the international, Phase 3, double-blind, placebo-controlled study, Secuado achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week six. Efficacy and safety were assessed during the six-week treatment period in 616 adults living with schizophrenia. Additionally, Secuado demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase 3 study.

The systemic safety profile of Secuado was consistent with what is known for sublingual asenapine.1 The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.1

What is Secuado?

Secuado is a prescription medicine used to treat adults with schizophrenia. Secuado is a transdermal system (patch) you apply to your skin. It is not known if Secuado is safe and effective in children less than 18 years of age with schizophrenia.

IMPORTANT SAFETY INFORMATION
 
Secuado may cause serious side effects, including:

· Increased risk of death in elderly people with dementia-related psychosis. Medicines like Secuado can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Secuado is not approved for the treatment of people with dementia-related psychosis.

· Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.

· Neuroleptic Malignant Syndrome (NMS): a serious condition that can lead to death. Immediately remove the patch. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following: high fever, confusion, stiff muscles, increased sweating and changes in your breathing, heart rate and blood pressure.

· Uncontrolled body movements (tardive dyskinesia). Secuado may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Secuado. Tardive dyskinesia may also start after you stop taking Secuado.

· Problems with your metabolism such as:

o High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Secuado.
Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Secuado:

§ Feel very thirsty or very hungry

§ Feel sick to your stomach

§ Feel weak or tired

§ Need to urinate more than usual

§ Feel confused, or your breath smells fruity

o Increased fat levels (cholesterol and triglycerides) in your blood

o Weight gain. You and your healthcare provider should check your weight regularly during treatment with Secuado.

· Allergic reactions. You may observe rash, decreased blood pressure or a fast heart rate.

· Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

· Falls. Secuado may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position, and can slow your thinking which may lead to falls.

· Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Secuado.

· Irregular heartbeat or a heartbeat that does not feel normal (QT prolongation)

· Increased prolactin levels in your blood (hyperprolactinemia). Your healthcare provider may do blood tests to check your prolactin levels during treatment with Secuado.

· Seizures (convulsions)

· Impaired thinking and motor skills. Use caution when operating heavy machinery when using Secuado.

· Problems controlling your body temperature so that you feel too warm

· Difficulty swallowing

· External heat. Avoid exposing Secuado to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc.

· Application site reactions. Increased skin irritation may occur if Secuado is applied for a longer period than instructed or if the same application site is used repeatedly. Use a different application site each day to decrease skin reactions. If skin reactions continue or spread beyond the application site, tell your healthcare provider. Symptoms of application site reactions may include:

o Redness

o Itching

o Irritation

o Pimple-like raised skin

o Pain of the skin

o Swelling

Do not use Secuado if you:

· Are allergic to asenapine or any other ingredients in Secuado.

· Have severe liver impairment

Before you use Secuado, tell your healthcare provider about all of your medical conditions, including if you have or have had:

· Heart problems or stroke

· Low or high blood pressure

· Diabetes or high blood sugar, or have a family history of diabetes or high blood sugar

· High levels of total cholesterol or triglycerides

· High prolactin levels

· Low white blood cell count

· Seizures

· Liver problems

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Secuado. It is not known if Secuado will harm your unborn baby.

· If you become pregnant during treatment with Secuado, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry.

Talk to your healthcare provider about the best way to feed your baby during treatment with Secuado. It is not known if Secuado passes into your breast milk.
 
 Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Secuado and other medicines may affect each other causing possible serious side effects. Secuado may affect the way other medicines work, and other medicines may affect how Secuado works.

The most common side effects of Secuado include:

· Restlessness, difficulty moving, muscle stiffness, tremor

· Skin irritation where the patch is placed

· Weight gain

Tell your healthcare provider if you have any side effects that bothers you or does not go away. These are not all the possible side effects of Secuado.
 
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Schizophrenia

Schizophrenia is a severe, chronic psychiatric disease with a heterogeneous course and symptom profile. The symptoms associated with schizophrenia are disabling and lifelong, and greatly affect a patient’s quality of life and social functioning. Symptoms usually start between ages 16 and 30 and fall into three categories: positive, negative and cognitive. Positive symptoms are psychotic behaviors not generally seen in healthy people and can include hallucinations, delusions, thought disorders and movement disorders. Negative symptoms are associated with disruptions to normal emotions and behaviors and can include flat affect (reduced expression of emotions), reduced feelings of pleasure in everyday life, difficulty beginning and sustaining activities and reduced speaking. Cognitive symptoms can include poor executive functioning (the ability to understand information and use it to make decisions), trouble focusing or paying attention and problems with working memory (the ability to use information immediately after learning it).3

1. 1 Secuado [prescribing information]. Miami, FL: Noven Therapeutics LLC; 2019.
2 Citrome, L, Zeni CM, Correll CU. Patches: Established and Emerging Transdermal treatments in psychiatry. J Clin Psychiatry 2019;90(4):18nr12554.
3 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/statistics/schizophrenia.shtml. Accessed September 2019.

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven’s mission is to develop and offer pharmaceutical products that meaningfully benefit patients around the world, with a commitment to advancing patient care through transdermal drug delivery. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as Hisamitsu’s U.S. platform in prescription pharmaceuticals, and helping Hisamitsu bring the benefits of patch therapy to the world. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.

Source: Noven Pharmaceuticals, Inc.

Posted: October 2019