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Posted by on Feb 21, 2020 in Parkinson's Disease | 0 comments

In a nutshell

This study investigated the safety and effectiveness of CVT-301 (Inbrija) for the treatment of wearing-off symptoms in patients with Parkinson's disease. Researchers suggested that this treatment was effective in improving off periods with no significant differences in side effects compared to standard levodopa.

Some background

Parkinson's disease (PD) affects brain cells. It is a chronic disease diagnosed in 60,000 Americans each year. Brain cells lose their abilities in controlling body functions causing symptoms such as tremors. The standard treatment is levodopa. However, the long-term use of levodopa is associated with side effects, such as wearing-off symptoms. Off episodes consist of the comeback of symptoms (sometimes worse) before the next dose of levodopa.

CVT-301 is an orally inhaled (breathing in through the mouth into the lungs) levodopa. This therapy enters the blood flow rapidly and in a predictive way. A greater number of patients treated with CVT-301 (58%) kept an ON-response through 60 minutes. However, too little is known about the safety of this treatment.

Methods & findings

This study included information about 310 patients with PD and wearing-off symptoms. These patients were assigned to receive CVT-301 (204) or standard levodopa (106). The study lasted for 12 months.

No significant differences in side effects were seen between both groups at 3 and 9 months. However, at 12 months, a significant reduction in lung function was seen in the standard therapy group. 

Wearing-off symptoms improved from before dose to 60 minutes after dosing for both groups. 80 to 85% of patients remained in ON-state for more than 60 minutes. More than 75% of patients reported improvement in the impression of change. Off times decreased by 1.32 to 1.42 hours a day.

The bottom line

This study concluded that CVT-301 improves Off-times in patients with PD without increasing safety concerns.

The fine print

This study was funded by Acorda Therapeutics, the manufacturer of CVT-301.

Published By :

Parkinsonism & related disorders

Date :

Dec 23, 2019

Original Title :

Inhaled levodopa in Parkinson’s disease patients with OFF periods: A randomized 12-month pulmonary safety study.

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