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.
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
Dec 23, 2019
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