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 the commercial availability of ONYDA™ XR (clonidine hydrochloride) extended-release oral suspension.

新泽西州蒙茅斯交界处（商业新闻）——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，今天宣布了ONYDA™XR（盐酸可乐定）缓释口服混悬液的商业可用性。

The U.S. Food and Drug Administration (FDA) approved the once-a-day liquid medication with nighttime dosing in May 2024 for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older..

美国食品和药物管理局（FDA）于2024年5月批准了一种每天一次的夜间给药液体药物，用于治疗多动症，作为单一疗法或作为6岁及以上儿科患者中枢神经系统（CNS）兴奋剂药物的辅助疗法。。

ONYDA XR is now available through national pharmaceutical wholesalers and patients can fill prescriptions for ONYDA XR through their local pharmacies across the United States.

ONYDA XR现在可以通过国家药品批发商获得，患者可以通过美国各地的当地药店填写ONYDA XR的处方。

“Non-stimulant ADHD therapies are an increasingly important option for patients who do not respond adequately to stimulant medications or experience negative side effects from them,” said Manesh Naidu, chief commercial officer at Tris Pharma. “As ADHD Awareness Month kicks off, we’re especially pleased that ONYDA XR is now available to patients in the United States who might benefit from it as the first-and-only liquid non-stimulant ADHD medication.

Tris Pharma首席商务官Manesh Naidu说：“对于那些对兴奋剂药物反应不足或产生负面副作用的患者来说，非兴奋剂ADHD治疗是一个越来越重要的选择。”。“随着ADHD意识月的开始，我们特别高兴的是，ONYDA XR现在可供美国患者使用，他们可能会从中受益，这是第一种也是唯一一种液体非兴奋剂ADHD药物。

We look forward to expanding access to this treatment and making a meaningful difference in the lives of those living with ADHD.”.

我们期待着扩大这种治疗的机会，并为多动症患者的生活带来有意义的改变。”。

ONYDA XR was developed using Tris Pharma’s proprietary drug-delivery technology to enable a once-a-day extended-release profile, and with its liquid formulation, patients now have an option that allows for easier administration in a range of doses. ONYDA XR is the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing..

ONYDA XR是使用Tris Pharma专有的药物输送技术开发的，以实现每天一次的缓释特性，并且通过其液体制剂，患者现在可以选择更容易地在一定剂量范围内给药。ONYDA XR是美国批准的第一种也是唯一一种液体非兴奋剂ADHD药物，也是唯一一种夜间给药的非兴奋剂ADHD药物。。

“As the prevalence of ADHD continues to grow, so does the need for the availability of a wider variety of treatment options that meet the unique and individual needs of patients,” said Rakesh Jain, MD, MPH, clinical professor, Texas Tech University School of Medicine – Permian Basin. “Until now, there has not been an extended-release oral suspension non-stimulant option available to people with ADHD who may struggle taking pills or require a longer-acting therapy.

德克萨斯理工大学二叠纪盆地医学院临床教授Rakesh Jain医学博士说：“随着ADHD患病率的持续增长，需要提供更广泛的治疗选择，以满足患者的独特和个人需求。”。“到目前为止，对于可能难以服用药物或需要长效治疗的多动症患者，还没有一种缓释口服混悬液非兴奋剂选择。

The availability of ONYDA XR represents a meaningful advancement in tailoring treatment to the diverse needs of people with ADHD, and I am excited to now have this important additional medicine available for my patients.”.

ONYDA XR的可用性代表了针对ADHD患者的不同需求量身定制治疗的有意义的进步，我很高兴现在能为我的患者提供这种重要的额外药物。”。

The U.S. FDA approval of ONYDA XR was based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets. Physicians can learn more at www.onydahcp.com.

美国FDA对ONYDA XR的批准是基于对盐酸可乐定缓释片的充分和良好控制的研究。医生可以在www.onydahcp.com上了解更多信息。

ONYDA XR is available by prescription to pediatric patients six years and older. More information, including financial support options, is available at www.onyda.com.

ONYDA XR可通过处方提供给六岁及以上的儿科患者。有关更多信息，包括财务支持选项，请访问www.onyda.com。

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。。

ONYDA (Clonidine hydrochloride)

ONYDA（盐酸可乐定）

INDICATION & IMPORTANT SAFETY INFORMATION

指示和重要安全信息

INDICATION

指示

ONYDA XR is a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

ONYDA XR是一种中枢作用的α2肾上腺素能激动剂，用于治疗6岁及以上儿童的注意力缺陷多动障碍（ADHD），作为单一疗法或中枢神经系统（CNS）兴奋剂药物的辅助疗法。

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications:

禁忌症：

ONYDA is contraindicated in patients with history of a hypersensitivity reaction to clonidine.

对可乐定有超敏反应史的患者禁用ONYDA。

Warnings & Precautions

警告和注意事项

Hypotension/Bradycardia: Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate. Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure.

低血压/心动过缓：用ONYDA XR治疗可导致血压和心率的剂量相关降低。对于有低血压、心脏传导阻滞、心动过缓、晕厥、心血管疾病、血管疾病、脑血管疾病或慢性肾衰竭风险的患者，缓慢滴定并经常监测生命体征。

In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated..

对于有晕厥病史或可能有晕厥倾向的患者，如低血压、体位性低血压、心动过缓或脱水，建议患者避免脱水或过热。。

Somnolence/Sedation: Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol..

嗜睡/镇静：嗜睡和镇静是盐酸可乐定缓释片临床研究中常见的不良反应。警告患者不要操作重型设备或驾驶，直到他们知道自己对ONYDA XR治疗的反应。建议患者避免饮酒。。

Cardiac Conduction Abnormalities: The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine.

心脏传导异常：可乐定的交感神经作用可能会加重窦房结功能障碍和房室传导阻滞，尤其是服用其他交感神经药物的患者。有上市后报告称，患有传导异常和/或服用其他交感神经药物的患者在服用可乐定时出现严重的心动过缓，需要静脉注射（IV）阿托品，静脉注射异丙肾上腺素和临时心脏起搏。

Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs..

缓慢滴定ONYDA XR，并经常监测心脏传导异常患者或同时接受其他交感神经药物治疗的患者的生命体征。。

Adverse Reactions:

Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth.

ADHD单药治疗最常见的不良反应（发生率至少为5%，是安慰剂的两倍）：嗜睡，疲劳，烦躁，噩梦，失眠，便秘，口干。

Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness.

作为ADHD精神兴奋剂的辅助治疗，最常见的不良反应（发生率至少为5%，是安慰剂的两倍）：嗜睡，疲劳，食欲下降，头晕。

Drug Interactions:

药物相互作用：

CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates, or other sedating drugs. Avoid concomitant use of CNS depressants with ONYDA XR.

中枢神经系统抑制剂：可乐定可能会增强酒精，巴比妥类药物或其他镇静药物对中枢神经系统的抑制作用。避免与ONYDA XR同时使用中枢神经系统抑制剂。

Tricyclic Antidepressants: Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Monitor blood pressure and adjust dosage of ONYDA XR as needed.

三环类抗抑郁药：三环类抗抑郁药与可乐定同时使用可增加血压，并可能抵消可乐定的降压作用。监测血压并根据需要调整ONYDA XR的剂量。

Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.

已知会影响窦房结功能或房室结传导的药物：避免将ONYDA XR与已知会影响窦房结功能或房室结传导的药物（例如洋地黄，钙通道阻滞剂和β受体阻滞剂）一起使用，因为可能会产生心动过缓和房室传导阻滞等累加效应。

Antihypertensive drugs: Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Monitor blood pressure and heart rate and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives.

抗高血压药物：抗高血压药物与可乐定同时使用可增强可乐定的降压作用。在同时服用抗高血压药的患者中，监测血压和心率，并相应调整ONYDA XR的剂量。

Use in specific population:

在特定人群中使用：

Use in patients with renal Impairment: The impact of renal impairment on the pharmacokinetics of clonidine in pediatric patients has not been assessed. The dosage of ONYDA XR must be adjusted according to the degree of impairment, and patients should be carefully monitored.

肾功能不全患者的使用：尚未评估肾功能不全对可乐定在儿科患者中的药代动力学的影响。必须根据损伤程度调整ONYDA XR的剂量，并应仔细监测患者。

Use during pregnancy: Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes..

怀孕期间的使用：根据已发表的文献，包括对照试验，回顾性队列研究和病例报告，几十年来孕妇长期服用可乐定，尚未发现与药物相关的重大出生缺陷，流产和不良孕产妇或胎儿结局的风险。。

To monitor pregnancy outcomes in women exposed to ADHD medications, including ONYDA XR, during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/adhd-medications/..

为了监测怀孕期间接触过多动症药物（包括ONYDA XR）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药物电话1-866-961-2388或在线访问https://womensmentalhealth.org/adhd-medications/..

Use during lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONYDA XR and any potential adverse effects on the breastfed child from ONYDA XR or from the underlying maternal condition. Monitor breastfeeding infants exposed to ONYDA XR through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding..

哺乳期使用：应考虑母乳喂养对发育和健康的益处，以及母亲对ONYDA XR的临床需求以及ONYDA XR或潜在母亲状况对母乳喂养孩子的任何潜在不利影响。监测通过母乳接触ONYDA XR的母乳喂养婴儿的低血压和/或心动过缓症状，如镇静、嗜睡、呼吸急促和喂养不良。。

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

要报告疑似不良反应，请联系Tris Pharma，Inc.，电话1-732-940-0358或FDA，电话1-800-FDA-1088或www.FDA.gov/medwatch

Please see ONYDA PI for full prescribing information

有关完整的处方信息，请参阅ONYDA PI