In this study, we assessed the safety and efficacy of CVT-301, a self-administered levodopa oral inhalation powder, for the treatment of patients with Parkinson's disease during off periods. Methods: In this randomised, double-blind, placebo-controlled, phase 3 trial, patients were recruited at 65 sites in Canada, Poland, Spain, and the USA.

在本研究中，我们评估了 CVT-301（一种自行给药的左旋多巴口服吸入粉剂）用于治疗停药期帕金森病患者的安全性和有效性。 方法 在这项随机、双盲、安慰剂对照的 3 期试验中，在加拿大、波兰、西班牙和美国的 65 个地点招募了患者。 符合条件的参与者是 30-85 岁的帕金森病患者，他们每天有 2 小时或更长时间的休息时间，并且在统一帕金森病评定量表 (UPDRS) 运动评分从关闭状态变为开启状态后显示出 25% 或更高的改善使用口服左旋多巴加多巴脱羧酶抑制剂组合。 患 …

涵盖领域： cvt-301 是一种干粉制剂，旨在通过肺部吸收向体循环提供左旋多巴。 介绍了该制剂的技术、药代动力学、功效和安全性数据。 专家意见：口服吸入是左旋多巴绕过胃肠道的一种新型给药方法，使左旋多巴比口服药物更快速、更可靠地进入体循环。

2016年10月21日 · cvt-301是一种由呼吸驱动吸入器递送的左旋多巴粉末配方，已被开发用于治疗帕金森病（pd）患者症状发作（在更换口服左旋多巴标准剂量时运动症状波动）。

2016年4月19日 · CVT-301 is a levodopa inhalation powder with the potential for rapid onset of action. The objective of this study was to evaluate CVT-301 self-administered by PD patients to relieve OFF episodes.

Areas covered: CVT-301 is a dry powder formulation designed to supply levodopa to the systemic circulation via pulmonary absorption. The technology, pharmacokinetics, efficacy, and safety data of this formulation are presented.

Rescue therapies can help patients taking oral medications who experience delayed onset symptom relief (delayed ON), and unexpected wearing OFF by providing rapid and durable symptoms relief. CVT-301, an inhaled LD formulation, provides a safe and effective delivery mechanism that may be preferred by patients over subcutaneous injections.

2021年4月19日 · CVT-301 is effective for the intermittent treatment of OFF episodes in patients with PD who are currently treated with carbidopa/levodopa. Based on study data and the FDA indication, it can be taken up to 5 times a day. CVT-301 bypasses the GI tract and is absorbed faster than oral medication.

近日，美国生物制药公司Acorda Therapeutics发表了其针对帕金森病的在研新药CVT-301的3期临床试验结果。 试验达到了主要终点，显着地改善了患者在“关闭”状态时的运动功能。

In this study, we assessed the safety and efficacy of CVT-301, a self-administered levodopa oral inhalation powder, for the treatment of patients with Parkinson's disease during off periods. In this randomised, double-blind, placebo-controlled, phase 3 trial, patients were recruited at 65 sites in Canada, Poland, Spain, and the USA.