Americans will soon have access to an infusion device that provides round-the-clock effective relief of Parkinson's disease. The US FDA this week approved the sale of the treatment, which harnesses innovative technology to make managing the condition easier and more impactful, will be available towards the end of 2025..

美国人将很快获得一种输液装置，该装置可24小时有效缓解帕金森氏病。美国食品和药物管理局（FDA）本周批准了该疗法的销售，该疗法利用创新技术使病情管理变得更容易和更具影响力，将于2025年底上市。。

The treatment, which will be sold under the name Onapgo, is essentially a subcutaneous – under the skin – device that allows for continuous infusion of the dopamine agonist apomorphine hydrochloride to reduce 'off' episodes. These episodes are periods during the day and night when lepodova medication wears off between doses and adverse motor-function symptoms (dyskensia) become amplified.

。这些发作是白天和晚上的一段时间，当lepodova药物在剂量之间逐渐消失，并且不良运动功能症状（运动障碍）被放大时。

In trial, Onapgo – formerly known as SPN-830 – significantly reduced these daily off episodes by an average of 2.47 hours, compared to the placebo treatment (0.58 hours)..

在试验中，Onapgo（以前称为SPN-830）与安慰剂治疗（0.58小时）相比，平均每天减少2.47小时。。

'The approval of Onapgo (SPN-830) is a significant milestone in Parkinson’s disease management,' Kelly Papesh, executive director of the Aossociation of Movement Disorder Advanced Practice Providers, recently told

AOAssociation of Motion Disorder Advanced Practice Providers执行董事凯利·帕佩什（KellyPapesh）最近告诉记者：“Onapgo（SPN-830）的批准是帕金森病管理的一个重要里程碑。”

NeurobiologyLive

神经生物学Live

. 'This therapy has the potential to be a game-changer, helping us provide more individualized and effective care to those living with Parkinson’s. Additionally, as more therapies like this are approved, it reinforces the need for continued innovation in drug development, particularly in delivering more consistent symptom control without relying solely on oral medications.'.

。此外，随着越来越多的此类疗法获得批准，它加强了药物开发持续创新的必要性，特别是在不完全依赖口服药物的情况下提供更一致的症状控制。”。

Developed by Supernus Pharmaceuticals, Onapgo does away with the hassle of needing to administer constant injections. Onapgo also doesn't need to be metabolized in the gut first, which ideally gives patients more control over their treatment and its efficacy.

由Supernus Pharmaceuticals开发的Onapgo消除了需要持续注射的麻烦。Onapgo也不需要首先在肠道代谢，这理想情况下可以让患者更好地控制治疗及其疗效。

'As

'作为

Parkinson’s disease

帕金森氏病

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 Dr Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, who was also one of the clinical trial investigators for Onapgo.

佛罗里达州博卡拉顿帕金森病和运动障碍中心主任斯图尔特·艾萨克森博士也是Onapgo的临床试验研究人员之一，他说，随着病情的发展，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，持续输注阿扑吗啡直接刺激突触后多巴胺受体，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。”。

The drug itself was first approved in 2004 under the brand name Apokyn, in the form of an injection pen that could be used up to five times a day. The newly approved infusion device can provide better symptom management without the need for surgery. The approval of the treatment will also be rolled out with an education program for healthcare professionals..

该药物本身于2004年首次获得批准，商标名为Apokyn，形式为注射笔，每天最多可使用五次。新批准的输液装置可以提供更好的症状管理，而无需手术。该疗法的批准还将与医疗保健专业人员的教育计划一起推出。。

More than 10 million people around the globe – a million in the US alone – are living with the progressive neurodegenerative disorder, and the uncontrolled movements seen in dyskinesia have a significant impact on quality of life and independence.

全球有1000多万人（仅美国就有100万人）患有进行性神经退行性疾病，运动障碍中不受控制的运动对生活质量和独立性产生重大影响。

“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 Dr Rajesh Pahwa, professor of Neurology at the University of Kansas School of Medicine, and another trial investigator.

堪萨斯大学医学院神经病学教授、另一位试验研究者Rajesh Pahwa博士说：“持续皮下注射阿扑吗啡在欧洲已有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..

“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，“良好的休息”时间也有类似的显着增加。。

'Today’s approval of Onapgo means patients in the US 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,' Pahwa added..

Pahwa补充道：“今天对Onapgo的批准意味着，美国患者对包括左旋多巴在内的当前治疗方案反应不佳，现在可以选择使用小型轻便的可穿戴设备进行连续输液，而无需进行侵入性外科手术。”。。

The trial results showed that the treatment was well tolerated overall, despite half a dozen patients dropping out due to worse side effects. In general, though, there were no unexpected safety concerns.

试验结果显示，尽管有六名患者因副作用更严重而退出治疗，但总体上治疗耐受性良好。不过，总的来说，没有意外的安全问题。

“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.

帕金森病与运动障碍联盟首席执行官安德里亚·梅里亚姆说：“随着帕金森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“开”与药物不起作用时“关”的交替状态。”。“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。”。

Supernus Pharmaceuticals is a US-based biopharmaceutical company that's focused on developing novel treatments for diseases that affect the central nervous system. It has invested more than four years in getting FDA approval for Onapgo.

Supernus Pharmaceuticals是一家总部位于美国的生物制药公司，专注于开发针对影响中枢神经系统疾病的新型治疗方法。它已经投入了四年多的时间来获得FDA对Onapgo的批准。

Late last year, drug company AbbVie

去年年底，AbbVie制药公司

received FDA approval

获得FDA批准

for its pump-based system that delivers a continuous supply of carbidopa and levodopa, the standard frontline treatment for Parkinson's disease.

其基于泵的系统可连续供应卡比多巴和左旋多巴，这是帕金森病的标准一线治疗方法。

Source:

资料来源：

Supernus Pharmaceuticals

Supernus 制药