FDA Approves Onapgo (apomorphine hydrochloride) for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s Disease

FDA批准Onapgo（盐酸阿扑吗啡）用于治疗晚期帕金森病成人的运动波动

ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved Onapgo (.

。

apomorphine

阿扑吗啡

hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make Onapgo available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch..

盐酸）注射液，以前称为SPN-830，是第一个也是唯一一个用于治疗晚期帕金森病（PD）成人运动波动的皮下阿扑吗啡输注装置。Supernus将在2025年第二季度提供Onapgo，并配备一个专家支持团队，包括一个强大的护士教育计划，并在启动时获得支持。。

“Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor fluctuations for thousands of patients,” said Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and a clinical trial investigator for Onapgo.

堪萨斯大学医学院神经病学教授、堪萨斯大学卫生系统运动障碍项目主任、Onapgo临床试验研究员拉杰什·帕瓦（Rajesh Pahwa）医学博士、拉弗恩（Laverne）和乔伊斯·里德（Joyce Rider）说：“持续皮下注射阿扑吗啡在欧洲已经有了30年的历史，它有助于为数千名患者提供更一致的运动波动控制。”。

“In a clinical trial in Europe, patients treated with Onapgo experienced a significant reduction in daily OFF time and a similar significant increase in GOOD ON time. Today’s approval of Onapgo means patients in the U.S. who are not responding well to their current treatment regimen, including levodopa, will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure.”.

“在欧洲的一项临床试验中，接受Onapgo治疗的患者每天的休息时间显着减少，准时率也有类似的显着增加。今天对Onapgo的批准意味着美国患者对目前的治疗方案（包括左旋多巴）反应不佳，现在可以选择使用小型轻便的可穿戴设备进行连续输注，而无需进行侵入性手术。”。

The approval is based on results from a Phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study (N=107) evaluating the efficacy and safety of Onapgo. The primary efficacy endpoint was the mean change in total daily OFF time assessed from baseline to the end of the 12-week treatment period based on patient diaries.

该批准基于评估Onapgo疗效和安全性的3期，12周，多中心，平行组，双盲，随机，安慰剂对照研究（N=107）的结果。主要疗效终点是根据患者日记从基线到12周治疗期结束评估的总每日休息时间的平均变化。

The key secondary endpoints were the mean change in daily GOOD ON time, which was defined as ON time without troublesome dyskinesia, and Patient Global Impression of Change (PGIC)..

。。

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“Onapgo represents a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Supernus’ significant experience in CNS has fueled the success of more than eight widely recognized products in CNS and other therapeutic categories.

Supernus Pharmaceuticals总裁兼首席执行官杰克·卡塔尔（JackKhattar）表示：“Onapgo代表了一种针对帕金森病患者的新方法，他们正在经历运动波动。”。“Supernus在中枢神经系统方面的丰富经验推动了中枢神经系统和其他治疗类别中八种以上广受认可的产品的成功。

The addition of Onapgo demonstrates our continued commitment to developing novel alternatives to manage Parkinson’s disease and other neurological conditions.”.

Onapgo的加入表明我们继续致力于开发新的替代品来治疗帕金森病和其他神经系统疾病。”。

'As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to GI dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain,' said Stuart Isaacson, M.D., Director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, and a clinical trial investigator for Onapgo.

佛罗里达州博卡拉顿帕金森病和运动障碍中心主任、Onapgo临床试验研究者斯图尔特·艾萨克森（StuartIsaacson）医学博士说：“随着帕金森病的进展，左旋多巴治疗在提供一致的运动控制方面往往效果不佳，部分原因是胃肠道运动障碍，口服药物的可变吸收以及由此产生的大脑多巴胺通路的脉动刺激。”。

'With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed. In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.'.

“使用Onapgo，阿扑吗啡的持续输注直接刺激突触后多巴胺受体，而不需要代谢转化。此外，阿扑吗啡的皮下递送绕过胃肠道进入大脑，这可以实现更可预测的症状改善。”。

“As the motor symptoms of Parkinson’s disease worsen over time, patients report alternating states between ON when their medication is working, and OFF when it’s not working optimally,” said Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance. “These on-again, off-again changes are disruptive and can happen at any time, which is why consistent daily control of OFF time is key to improving how patients feel and move.

帕金森与运动障碍联盟首席执行官安德里亚·梅里亚姆（AndreaMerriam）说：“随着帕金森氏病的运动症状随着时间的推移而恶化，患者报告说，药物起作用时处于开启状态，而药物不起作用时处于关闭状态。”。“这些反复开关的变化具有破坏性，并且可以随时发生，这就是为什么每天持续控制休息时间是改善患者感觉和行动的关键。

For many, continuous treatment options like Onapgo can help to make days with Parkinson’s more predictable.”.

对于许多人来说，像Onapgo这样的持续治疗选择可以帮助帕金森氏症的日子变得更加可预测。”。

About the Phase 3 Study

关于第三阶段研究

During the Phase 3 study, Onapgo significantly reduced the amount of daily OFF time at 12 weeks from baseline (p=0.0114), with Onapgo-treated patients (n=53) experiencing a 2.6-hour reduction compared to placebo (n=51) with 0.9 hours. The reduction in daily OFF time was accompanied by a similar significant increase in daily GOOD ON time (2.8 hours for Onapgo-treated patients compared to 1.1 hours for the placebo group; p=0.0188)..

在第三阶段研究中，Onapgo显着减少了基线12周的每日休息时间（p=0.0114），Onapgo治疗的患者（n=53）与安慰剂（n=51）相比减少了2.6小时，0.9小时。每日休息时间的减少伴随着每日良好准时的类似显着增加（Onapgo治疗患者为2.8小时，而安慰剂组为1.1小时；p=0.0188）。。

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* In addition, numerically greater improvements in daily OFF time and daily GOOD ON time were seen as early as week 1 and were maintained throughout all measured timepoints. Additionally, Onapgo-treated patients more frequently reported improvement in their state of general health compared with placebo-treated patients (PGIC: 79% vs.

*此外，早在第1周，每天的休息时间和每天良好的准时性就得到了较大的改善，并且在所有测量的时间点都得到了保持。此外，与安慰剂治疗的患者相比，Onapgo治疗的患者更常报告其总体健康状况有所改善（PGIC:79%vs。

24%; p<0.0001). The most common adverse events (≥10% incidence) were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia..

；p＜0.0001）。最常见的不良事件（≥10%发生率）是输液部位结节，恶心，嗜睡，输液部位红斑，运动障碍，头痛和失眠。。

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About Parkinson’s disease

关于帕金森氏病

Nearly one million people in the U.S. and more than 10 million people worldwide are living with Parkinson’s disease, a progressive and chronic neurodegenerative disorder that can cause tremors, muscle rigidity, and difficulty with movement and balance. Patients may also experience dyskinesia, involuntary movements that can significantly interfere with daily activities..

美国近100万人和全世界1000多万人患有帕金森氏病，帕金森氏病是一种进行性慢性神经退行性疾病，可引起震颤、肌肉僵硬以及运动和平衡困难。患者还可能出现运动障碍，不自主运动，可能会严重干扰日常活动。。

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The disease impacts the central nervous system (e.g., the brain and spinal cord) and the peripheral nervous system, the network of nerves that support the limbs and the organs of the body (e.g., GI system including digestion, respiration, heart function, and blood pressure).

该疾病影响中枢神经系统（例如大脑和脊髓）和周围神经系统，支持四肢和身体器官的神经网络（例如胃肠系统，包括消化，呼吸，心脏功能和血压）。

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While there is no known cure for PD, there are treatments available to help reduce symptoms.

虽然目前还没有已知的PD治疗方法，但有一些治疗方法可以帮助减轻症状。

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Patients treated with mainstay regimens may experience periods of GOOD ON time when medication treatment is working well, or OFF time when oral levodopa no longer provides symptom benefit and motor symptoms return.

当药物治疗效果良好时，接受主流方案治疗的患者可能会经历良好的准时期，或者当口服左旋多巴不再提供症状益处和运动症状恢复时，可能会经历休息期。

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PD is the second most common neurodegenerative disorder of aging and the most common movement disorder.

PD是衰老中第二常见的神经退行性疾病，也是最常见的运动障碍。

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USE

使用

Onapgo is a prescription medicine used to treat motor fluctuations (OFF episodes) in adults with advanced Parkinson’s disease (PD). It is not known if Onapgo is safe and effective in children.

Onapgo是一种处方药，用于治疗晚期帕金森病（PD）成人的运动波动（非发作）。目前尚不清楚Onapgo对儿童是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

Do not take Onapgo if you are

如果你是，不要服用Onapgo

:

:

Call your healthcare provider or get emergency help right away if you have any of the following symptoms of severe life-threatening allergic reaction

如果您有以下任何严重危及生命的过敏反应症状，请立即致电您的医疗保健提供者或寻求紧急帮助

:

:

Before you start using Onapgo, tell your healthcare provider about all of your medical conditions, including

在开始使用Onapgo之前，请告知您的医疗保健提供者您的所有医疗状况，包括

:

:

Tell your healthcare provider about all the medicines you take

告诉你的医疗保健提供者你服用的所有药物

, including prescription and non-prescription (over-the-counter) medicines, vitamins, and herbal supplements. Onapgo and certain other medicines may affect each other and cause serious side effects.

，包括处方药和非处方药（非处方药），维生素和草药补充剂。Onapgo和某些其他药物可能会相互影响并引起严重的副作用。

What should I avoid while using Onapgo?

使用Onapgo时应该避免什么？

What are the possible side effects of Onapgo?

Onapgo可能有哪些副作用？

Onapgo may cause serious side effects, including:

Onapgo可能会引起严重的副作用，包括：

Other common side effects of Onapgo include

Onapgo的其他常见副作用包括

headache and trouble falling asleep or staying asleep (insomnia).

。

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

鼓励您向FDA报告处方药的负面副作用。访问

www.fda.gov/medwatch

政府/医疗观察

, or call 1-800-FDA-1088.

，或致电1-800-FDA-1088。

Patients and care partners must receive complete instructions on the proper use of Onapgo. Please see

患者和护理合作伙伴必须获得正确使用Onapgo的完整说明。

Patient Information

患者信息

and

和

Patient Instructions for Use

患者使用说明

and talk to your healthcare provider.

并与您的医疗保健提供者交谈。

Onapgo (apomorphine hydrochloride) injection, for subcutaneous use, is available in a 98 mg/20 mL (4.9 mg/mL) apomorphine hydrochloride solution.

皮下使用的Onapgo（盐酸阿扑吗啡）注射液可在98 mg/20 mL（4.9 mg/mL）盐酸阿扑吗啡溶液中获得。

References

参考文献

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Onapgo. Package insert. Supernus Pharmaceuticals, Inc

奥纳普戈。包装插页。Supernus制药公司

.

.

*

*

Efficacy results from the analysis of data from the TOLEDO study using the FDA’s preferred methodology, mixed-effects model for repeated measures (MMRM), as required for the submission of the New Drug Application. The results confirmed the statistical significance of the primary outcome.

根据提交新药申请的要求，使用FDA的首选方法，重复测量混合效应模型（MMRM）对托莱多研究的数据进行分析，得出疗效结果。结果证实了主要结果的统计学意义。

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Parkinson’s Foundation. Understanding Parkinson’s. Parkinson’s Foundation. 2024. Accessed December 2024.

帕金森基金会。了解帕金森氏症。帕金森基金会。2024年。2024年12月访问。

https://www.parkinson.org/understanding-parkinsons

https://www.parkinson.org/understanding-parkinsons

.

.

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American Parkinson Disease Association. Peripheral neuropathy and Parkinson’s disease. 2020. Accessed December 2024.

。周围神经病变和帕金森氏病。2020年。2024年12月访问。

https://www.apdaparkinson.org/article/peripheral-neuropathy-parkinsons-disease/

https://www.apdaparkinson.org/article/peripheral-neuropathy-parkinsons-disease/

.

.

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World Health Organization. Parkinson disease. 2023. Accessed December 2024.

世界卫生组织。帕金森病。2023年。2024年12月访问。

https://www.who.int/news-room/fact-sheets/detail/parkinson-disease

https://www.who.int/news-room/fact-sheets/detail/parkinson-disease

.

.

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Isaacson S, Pagan F, Lew M, Pahwa R. Should “on-demand” treatments for Parkinson’s disease OFF episodes be used earlier?

Isaacson S，Pagan F，Lew M，Pahwa R.是否应该尽早使用帕金森病非发作期的“按需”治疗？

Sci Direct.

Sci直接。

2022;8:100161.

2022;8:100161.

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Mhyre TR, Boyd JT, Hamill RW, Maguire-Zeiss KA. Parkinson’s disease. Subcell Biochem. 2012;65:389–455. doi:10.1007/978-94-007-5416-4_16.

Mhyre TR，Boyd JT，Hamill RW，Maguire Zeiss KA。帕金森氏病。亚细胞生物化学。2012年；65:389-455。doi:10.1007/978-94-007-5416-4\u 16。

About Supernus Pharmaceuticals, Inc.

。

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Supernus Pharmaceuticals是一家生物制药公司，专注于开发和商业化用于治疗中枢神经系统（CNS）疾病的产品。

Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders..

我们多样化的神经科学组合包括针对注意力缺陷多动障碍（ADHD）的批准治疗，接受左旋多巴治疗的帕金森病（PD）患者的运动障碍，PD的低活动性，癫痫，偏头痛，宫颈肌张力障碍和慢性流涎。我们正在开发广泛的新型中枢神经系统候选产品，包括针对PD，癫痫，抑郁症和其他中枢神经系统疾病的低活动性的新潜在治疗方法。。

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

有关更多信息，请访问www.supernus.com。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

。这些陈述并不传达历史信息，而是与基于管理层当前预期的预测或潜在未来事件有关。这些报表存在风险和不确定性，可能导致实际结果与此类报表明示或暗示的结果存在重大差异。

In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s reporting on preliminary and exploratory open label clinical study on SPN-820, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries including Onapgo; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-820; the Company’s ability to protect its intellectual property and operate .

除了本新闻稿中提到的因素外，此类风险和不确定性还包括但不限于公司关于SPN-820初步和探索性开放标签临床研究的报告，公司维持和增加盈利能力的能力；公司筹集足够资金以全面实施公司战略的能力；公司企业战略的实施；公司未来的财务业绩和预计支出；公司增加其每种产品及其子公司产品处方数量的能力；公司增加净收入的能力；公司将其产品及其子公司（包括Onapgo）的产品商业化的能力；公司未来与制药公司和学术机构合作或从政府机构获得资金的能力；公司的产品研发活动，包括公司临床试验的时间和进度以及预计支出；；公司保护其知识产权和运营的能力。

Source: Supernus Pharmaceuticals, Inc.

资料来源：Supernus Pharmaceuticals，Inc。

Onapgo (apomorphine hydrochloride) FDA Approval History

Onapgo（盐酸阿扑吗啡）FDA批准历史

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