MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced additional ex-US regulatory approvals of Quillivant® XR (methylphenidate HCl extended-release oral suspension) and QuilliChew® ER (methylphenidate HCl extended-release chewable tablets) for the treatment of ADHD..

新泽西州蒙茅斯交界处（商业新闻短讯）--Tris Pharma，Inc.（Tris），一家专注于注意力缺陷多动障碍（ADHD），疼痛，成瘾和神经系统疾病的商业阶段生物制药公司，今天宣布额外获得美国监管机构批准的Quillivant®XR（盐酸哌甲酯缓释口服混悬液）和QuilliChew®ER（盐酸哌甲酯缓释咀嚼片）用于治疗ADHD。。

In October, the Saudi Food & Drug Authority (SFDA) approved these products as Quillivant XR Suspension and Quillivant XR Prolonged-Release Tablets for the treatment of ADHD in patients six years and above. Earlier this year, the National Medical Products Administration (NMPA) in China approved Quillivant XR as Methylphenidate Hydrochloride for Sustained-Release Suspension for the treatment of ADHD in patients six years and above; this follows last year’s NMPA approval of QuilliChew ER as Methylphenidate Hydrochloride Extended-Release Chewable Tablets for the treatment of ADHD in patients six years and above.

10月，沙特食品和药物管理局（SFDA）批准这些产品为Quillivant XR混悬剂和Quillivant XR缓释片，用于治疗6岁及以上患者的ADHD。今年早些时候，中国国家医药产品管理局（NMPA）批准Quillivant XR作为盐酸哌醋甲酯缓释混悬液用于治疗6岁及以上患者的ADHD；此前，去年NMPA批准QuilliChew ER作为盐酸哌醋甲酯缓释咀嚼片用于治疗六岁及以上患者的ADHD。

Additionally, Quillivant XR received approval from the Pharmaceutical Division of the Ministry of Health in Israel for the treatment of ADHD earlier this year. Tris Pharma is actively seeking partnerships to facilitate the distribution and availability of Quillivant XR in Israel..

此外，Quillivant XR今年早些时候获得以色列卫生部制药司批准用于治疗ADHD。Tris Pharma正在积极寻求合作伙伴关系，以促进Quillivant XR在以色列的分销和供应。。

The additional regulatory clearances expand the international availability of these medications beyond Canada, where last year Health Canada authorized the use of these products as Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets for the treatment of ADHD in children ages six to 12. These medications are manufactured in the United States and exported to countries where each has received regulatory approval..

额外的监管许可将这些药物的国际供应范围扩大到加拿大以外，去年加拿大卫生部授权将这些产品用作Quillivant ER口服混悬剂和Quillivant ER咀嚼片，用于治疗6至12岁儿童的ADHD。这些药物在美国制造，并出口到各自获得监管批准的国家。。

“These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs,” said Ketan Mehta, founder and CEO at Tris Pharma. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.”.

。“随着被诊断患有多动症的人数增加，许多国家继续面临药物短缺，我们很自豪地从我们强大的多动症产品组合中扩大产品的可用性，以潜在地支持全球数百万患有多动症的人。”。

Quillivant XR has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant XR oral suspension allows for personalized dosing with ease of titration and the QuilliChew ER chewable tablets have scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet.

Quillivant XR已证明在给药后45分钟至12小时内就开始起作用，从而在一天中提供一致的连续递送。Quillivant XR口服混悬液允许个性化给药，易于滴定，QuilliChew ER咀嚼片具有评分片剂，这是儿科患者的理想选择，为剂量给药提供了额外的灵活性，在缓释哌醋甲酯片剂中提供了最多的剂量选择。

Tris developed both formulations using the company’s proprietary LiquiXR® technology..

Tris使用公司专有的LiquiXR®技术开发了这两种配方。。

ADHD diagnosis rates continue to rise globally, likely driven by increased awareness and better diagnostic practices. It is estimated that approximately 129 million children and adolescents aged 5-19 and more than 366 million adults worldwide have ADHD.1-2

多动症的诊断率在全球范围内持续上升，这可能是由于意识的提高和更好的诊断实践。据估计，全世界约有1.29亿5-19岁的儿童和青少年以及超过3.66亿成年人患有ADHD.1-2

About Tris Pharma

关于Tris Pharma

Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates.

Tris Pharma是一家私营、创新驱动的生物制药公司，正在应用其药物开发能力和专有技术来改变多动症、疼痛、成瘾和中枢神经系统疾病的治疗方法。Tris是一家成熟的商业组织，拥有一流的ADHD产品的强大组合，以及有前途的差异化近期候选药物渠道。

More information is available at www.trispharma.com and on LinkedIn @TrisPharma..

更多信息请访问www.trispharma.com和LinkedIn@trispharma。。

References

参考文献

1 General Prevalence of ADHD. Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).

1 ADHD的一般患病率。患有注意力缺陷/多动障碍（CHADD）的儿童和成人。

2 Song P, Zha M, Yang Q, et al. The prevalence of adult attention-deficit hyperactivity disorder: A global systematic review and meta-analysis. Journal of Global Health. 2021;11:04009.

2 Song P，Zha M，Yang Q，等。成人注意缺陷多动障碍的患病率：全球系统评价和荟萃分析。全球卫生杂志。；11： 04009年。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: ABUSE, MISUSE, AND ADDICTION

警告：滥用、误用和成瘾

Quillivant XR, QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction.

Quillivant XR，QuilliChew ER有很高的滥用和滥用潜力，这可能导致药物使用障碍的发展，包括成瘾。中枢神经系统兴奋剂（包括Quillivant XR，QuilliChew ER）的滥用和滥用可能导致过量服用和死亡。在开具Quillivant XR，QuilliChew ER之前，评估每位患者滥用，误用和成瘾的风险。

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction..

教育患者及其家属了解这些风险，正确储存药物以及正确处置任何未使用的药物。在整个治疗过程中，重新评估每位患者的风险，并经常监测虐待，误用和成瘾的迹象和症状。。

Quillivant XR and QuilliChew ER are contraindicated:

in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.

已知对哌醋甲酯或Quillivant XR和QuilliChew ER的其他成分过敏的患者。据报道，过敏反应如血管性水肿和过敏反应。

during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.

在单胺氧化酶抑制剂（MAOIs）的伴随治疗期间，以及由于高血压危象的风险而停止MAOI治疗后14天内。

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with Quillivant XR and QuilliChew ER, assess for the presence of cardiac disease.

据报道，患有结构性心脏异常或其他严重心脏病的患者在推荐的ADHD剂量下接受中枢神经系统兴奋剂治疗后猝死。过量服用严重的心血管影响可能导致心脏猝死。。

Avoid Quillivant XR and QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR and QuilliChew ER..

。进一步评估Quillivant XR和QuilliChew ER治疗期间出现劳力性胸痛，不明原因晕厥或心律不齐的患者。。

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

中枢神经系统兴奋剂会导致血压升高（平均升高约2-4毫米汞柱）和心率升高（平均升高约3-6 bpm）。一些人可能会有更大的增长。监测所有患者的高血压和心动过速。

Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage.

中枢神经系统兴奋剂的使用可能会导致先前存在的精神病恶化，并可能诱发躁郁症患者的躁狂或混合发作。在没有精神病或躁狂病史的患者中，中枢神经系统兴奋剂可能会在推荐剂量下引起新的精神病或躁狂症状（例如幻觉，妄想或躁狂）。

Prior to initiating Quillivant XR and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR, and QuilliChew ER..

在开始Quillivant XR和QuilliChew ER治疗之前，筛查患者发生躁狂发作的危险因素。如果出现新的精神病或躁狂症状，请考虑停用Quillivant XR和QuilliChew ER。。

Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR and QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections..

据报道，在成年和儿科男性患者中，使用哌醋甲酯和停药期间都有阴茎异常勃起的病例。Quillivant XR和QuilliChew ER治疗的患者出现异常持续或频繁且痛苦的勃起，应立即就医。。

CNS stimulants including Quillivant XR and QuilliChew ER used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

用于治疗ADHD的中枢神经系统兴奋剂包括Quillivant XR和QuilliChew ER与外周血管病变有关，包括雷诺现象。体征和症状通常是间歇性和轻度的；。在使用ADHD兴奋剂治疗期间，必须仔细观察数字变化。

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Quillivant XR and QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy..

进一步的临床评估（例如风湿病转诊）可能适用于Quillivant XR和QuilliChew ER治疗的出现外周血管病变体征或症状的患者。。

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR and QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted..

中枢神经系统兴奋剂与儿科患者的体重减轻和生长速度减慢有关。在使用兴奋剂（包括Quillivant XR和QuilliChew ER）治疗期间，应监测生长情况。没有按预期生长或体重增加的患者可能需要中断治疗。。

QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER.

QuilliChew ER含有苯丙氨酸（阿斯巴甜的一种成分），可能对苯丙酮尿症（PKU）患者有害。在为PKU患者开具QuilliChew ER之前，请考虑包括QuilliChew ER在内的所有来源的苯丙氨酸每日总量。

Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

Quillivant XR和QuilliChew ER治疗的患有急性闭角型青光眼风险的患者（例如患有严重远视的患者）应由眼科医生进行评估。

Quillivant XR and QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary.

Quillivant XR和QuilliChew ER应该用于开角型青光眼或眼压异常升高的患者，只有在治疗的益处被认为大于风险的情况下。有必要密切监测有眼压升高或开角型青光眼病史的患者。

CNS stimulants, including methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR and QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.

中枢神经系统兴奋剂，包括哌醋甲酯产品，与运动和言语抽搐的发作或恶化以及图雷特氏综合征的恶化有关。在开始Quillivant XR和QuilliChew ER之前，评估家族史并临床评估患者的抽动症或图雷特氏综合征。

Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate..

定期监测患者抽搐或抽动秽语综合征的出现或恶化。如果临床上合适，停止治疗。。

Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are:

根据其他哌醋甲酯产品的累积数据，最常见的不良反应（≥5%，是安慰剂的两倍）是：

Appetite decreased.

食欲下降。

Insomnia

失眠

Nausea

恶心

Vomiting

呕吐

Dyspepsia

消化不良

Abdominal pain

腹痛

Weight decreased

Anxiety

焦虑

Dizziness

头晕

Irritability

易怒

Affect lability

影响不稳定性

Tachycardia

心动过速

Blood pressure increased

血压升高

There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.

Quillivant XR和QuilliChew ER在对照试验中的经验有限。

Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%)..

Quillivant XR：与安慰剂相比，Quillivant XR中45名ADHD患者（6-12岁）进行的3期对照研究中报告的最常见（Quillivant XR组≥2%，大于安慰剂）不良反应是影响不稳定性（9%Quillivant XR，2%安慰剂），排尿（4%，0%），初始失眠（2%，0%），抽搐（2%，0%），食欲下降（2%，0%），呕吐（2%，0%），晕动病（2%，0%），眼痛（2%，0%）和皮疹（2%，0%）。。

QuilliChew ER: The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6-12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%)..

QuilliChew ER：与安慰剂相比，在QuilliChew ER的90名儿科受试者（6-12岁）进行的3期对照研究中，最常见的不良反应（QuilliChew ER组≥2%，大于安慰剂）是食欲下降（2.4%QuilliChew ER，0%安慰剂），攻击性（2.4%，0%），情绪贫困（2.4%，0%），恶心（2.4%，0%），头痛（2.4%，0%）和体重下降（2.4%，0%）。。

There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition.

关于孕妇使用哌醋甲酯的研究有限。然而，据报道，苯丙胺依赖的母亲早产和低出生体重儿。应考虑母乳喂养对发育和健康的益处，以及母亲对Quillivant XR和QuilliChew ER的临床需求，以及Quillivant XR和QuilliChew ER或潜在的母亲状况对母乳喂养婴儿的任何潜在不利影响。

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain..

监测母乳喂养婴儿的不良反应，如躁动、失眠、厌食和体重增加减少。。

To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/..

为了监测怀孕期间接触过多动症药物的女性的妊娠结局，鼓励医疗保健提供者通过拨打国家妊娠登记处的精神兴奋剂电话1-866-961-2388或在线访问https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/..

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

INDICATION

指示

Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

。

Please see Full Prescribing Information for Quillivant XR and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

请参阅Quillivant XR和QuilliChew ER的完整处方信息，包括关于滥用，误用和成瘾的盒装警告。