2018年12月24日，Acorda制药宣布，美国食品和药物管理局（FDA）批准INBRIJA用于接受卡比多巴/左旋多巴治疗的帕金森病关闭期（OFF）间歇性治疗。

  Acorda总裁兼首席执行官Ron Cohen博士表示，“公司旗下INBRIJA获得FDA批准，标志着Acorda和帕金森氏症群体的一个重要里程碑，我们很高兴能够开发出这种临床上急需的治疗方法，这个里程碑源于20多年的研究和开发，从麻省理工学院Robert Langer博士的实验室开始，通过整个Acorda团队多年的坚持不懈和独创性研究，终于获得了成功。”
  INBRIJA是一款便于患者自己操作的吸入式左旋多巴，用于治疗目前在使用卡比多巴/左旋多巴的帕金森病患者关闭期症状。INBRIJA利用Acorda的ARCUS平台开发，旨在向肺部提供精确剂量的左旋多巴干粉制剂。口服药物需要先通过肠胃吸收再到达大脑，所以起效过程会有变化。而吸入式治疗可以通过肺部进入身体，直达大脑，绕过了消化系统。

  INBRIJA获批是基于临床3期疗效关键试验SPANSM-PD，这是一项为期12周、随机、安慰剂对照的双盲研究，试验的目标是评估INBRIJA对轻度至中度帕金森氏症患者经历OFF期的有效性。受试者包括约900例接受卡比多巴/左旋多巴方案的、正在遭受开-关现象折磨的帕金森患者。在过去两周内服用或曾服用非选择性单胺氧化酶抑制剂（如苯乙肼或反苯环丙胺）的患者不能使用INBRIJA。试验结果显示，SPAN-PD试验符合其主要终点，患者在第12周随访时显示运动功能的统计学上发生显著改善，通过统一帕金森病评定量表（UPDRS）第III部分来衡量，INBRIJA给药84 mg（n = 114）与安慰剂（n = 112）相比，给药后30分钟两者的数值分别为-9.83分和-5.91分（ p = 0.009）。关键试验中，INBRIJA最常见的不良反应（至少5％，大于安慰剂）是咳嗽（15％vs 2％），上呼吸道感染（6％ vs. 3％），恶心（5％ vs. 3％）和痰液变色（5％ vs. 0％）。
  此外，INBRIJA还开展了一项3期长期、主动控制、随机、开放标签研究（N = 398），评估了一年内的药物安全性和耐受性。该研究显示，INBRIJA组患者和观察组患者的FEV1（一秒用力呼气容积）的平均降低幅度相同（-0.1 L）。过去五年内患有慢性阻塞性肺病（COPD）、哮喘或其他慢性呼吸道疾病的患者被排除在本研究之外。

  帕金森病是由于某些负责产生多巴胺的神经元逐渐丧失而引起的进行性神经退行性疾病，会导致一系列症状，包括运动受损、肌肉僵硬和震颤。目前，卡比多巴/左旋多巴剂量是帕金森氏症口服治疗标准药物。“开-关现象”（ON-OFF）是帕金森病人药物治疗后期的并发症。“开”是指药物治疗对病人起到明显的治疗效果，病人能运动；“关”是指病人在接受治疗一段时间后运动能力丧失，这是由于口服之间的低水平多巴胺引起的。这种变化速度可以非常快，并且是不可预测的。病人形容病情的变化就象是电源的开、关一样，所以临床上形象地称这种现象为开-关现象。随着疾病进展，患者会经历关闭期，表现为帕金森病的症状再现。目前，在美国和欧洲分别有100万和120万帕金森病患者，其中经历关闭期的患者分别为35万和42万。即使患者的治疗方案已经优化，这种症状的再现还是会发生。这些患者急需有效的治疗方法来控制病情。
  Michael J. Fox基金会首席执行官Todd Sherer博士说，“尽管帕金森患者目前可以接受相应的治疗，但随着帕金森病的进展，患者可能会出现OFF期，开-关现象会随着药物治疗时间的延长愈发的严重，这可能具有严重的破坏性，基金会为INBRIJA的早期临床开发提供了相应资金，因为患者告诉我们OFF期是他们面临的最严重问题之一。我们知道必须帮助解决这一未满足的临床需求，这此批准是帕金森研究向前迈出的重要一步，因为它提供了一种新的治疗方案来更好的控制这些症状。”
  神经病学教授、帕金森病主任、南佛罗里达大学运动障碍中心医学博士MBA Robert A. Hauser认为，“在临床研究计划中，INBRIJA证明了药物安全性，并通过试验证实了用药后可以获得运动功能临床意义上的改善，INBRIJA有助于解决当前帕金森症患者的重大临床需求，我们期待在更多的医疗单位在帕金森治疗中添加这种新的治疗方案。”
  Acorda首席医疗官Burkhard Blank说，“我很高兴INBRIJA已经获得FDA批准，这项批准将可能允许根据患者的个体需求，增加患者现有的帕金森药物的选择范围。感谢FDA在整个发展计划中与我们进行了建设性对话，并在审查周期内建立了良好的伙伴关系。我们特别感谢所有自愿参加INBRIJA临床试验的受试者，没有他们的承诺，我们也无法成功开发新的药物。感谢帕金森病患者，他们的护理合作伙伴、研究人员、临床医生和相关公益团体，他们与我们合作，共同帮助实现了这一里程碑。”

  完整说明书附件：http://www.inbrija.com/prescribing-information.PDF
Inbrija(levodopa inhalation powder)
Additional Important Safety Information
Before using INBRIJA, patients should tell their healthcare provider about all their medical conditions, including:
asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
daytime sleepiness from a sleep disorder or if they get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics
feel dizzy, nausea, sweaty, or faint when standing from sitting/lying down
history of abnormal movement (dyskinesia)
mental health problem such as hallucinations or psychosis
uncontrollable urges (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating)
glaucoma
pregnancy or plans to become pregnant. It is not known if INBRIJA will harm an unborn baby.
breastfeeding or plans to breastfeed. Levodopa (the medicine in INBRIJA) can pass into breastmilk and it is unknown if it can harm the baby.
Patients should tell their healthcare provider if they take:
MAO-B inhibitors
dopamine D2 receptor antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide), or isoniazid
iron salts or multivitamins that contain iron salts
No more than 1 dose (2 capsules) should be taken for any OFF period. No more than 5 doses (10 capsules) of INBRIJA should be taken in a day.
INBRIJA is for oral inhalation only. INBRIJA capsules are not to be swallowed or opened.
Patients are not to drive, operate machinery, or do other activities until they know how INBRIJA affects them. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.
INBRIJA (levodopa inhalation powder) can cause serious side effects including the following. Patients should tell their healthcare provider if they experience them:
falling asleep during normal daily activities (such as driving, doing physical tasks, using hazardous machinery, talking, or eating) and can be without warning. If patients become drowsy while using INBRIJA, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicines that cause sleepiness.
withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) in patients who suddenly lower or change their dose or stop using INBRIJA or carbidopa/levodopa medicines.
low blood pressure with or without dizziness, fainting, nausea, and sweating. Patients should get up slowly after sitting or lying down.
hallucinations and other psychosis – INBRIJA may cause or worsen psychotic symptoms including hallucinations (seeing/hearing things that are not real); confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm them; believing things that are not real, acting aggressive, and feeling agitated/restless.
unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicines like INBRIJA.
uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by INBRIJA. INBRIJA may need to be stopped or other Parkinson’s medicines may need to be changed.
bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling INBRIJA. If patients have these symptoms, they should stop taking INBRIJA and call their healthcare provider or go to the nearest hospital emergency room right away.
increased eye pressure in patients with glaucoma. Healthcare providers should monitor this.
changes in certain lab values including liver tests.
The most common side effects of INBRIJA include cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.