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Posted by on Dec 31, 2019 in Parkinson's Disease | 0 comments

In a nutshell

This study investigated the effectiveness of sublingual apomorphine (Apokyn) in the treatment of off times in patients with Parkinson's disease. Researchers suggested that this treatment might be a safe and effective option for the treatment of these patients.

Some background

Parkinson's disease (PD) is the second most common brain disease in North America. This disease affects brain cells. These cells lose their abilities leaving the patients with symptoms such as tremors.

Levodopa remains the most effective treatment. However, long-term use of levodopa is associated with wearing-off symptoms that affect up to 90% of the patients. During off-times, PD symptoms come back (sometimes worse) before the next dose of levodopa.

Another approved for the treatment of PD is apomorphine. This drug is similar to levodopa in terms of anti-PD effects. However, it is associated with severe side-effects, including skin reaction to apomorphine injections. Sublingual apomorphine (SAM) consists of a film with two layers containing apomorphine, that is placed under the tongue. SAM is absorbed through the mouth inner lining (mucosa) avoiding the need for injections. This also improves the drug levels in the blood over time, which improves wearing-off symptoms. 

Prior studies suggested that SAM was well tolerated, and most patients achieved a full-on response within 30 minutes. However, the effectiveness and safety of SAM in the treatment of off symptoms is still not fully clear.

Methods & findings

This study included information about 109 patients. Of these 54 received SAM and 55 received placebo (a drug with no effect in the body). The study lasted for 12 weeks. 

Patients receiving SAM saw a greater change from before treatment and 30 minutes after treatment.

Moderate mouth side effects were reported in 17 (31%) patients in the SAM group and in 4 (7%) in the placebo group. Of these 9 (17%) patients stopped treatment in the SAM group and 1 (2%) patient in the placebo group.

These patients also experienced nausea (28%), sleepiness (13%) and dizziness (9%). One patient (with known heart disease) in the SAM group died of a heart attack.

The bottom line

This study concluded that SAM provided a safe treatment for wearing-off symptoms in patients with Parkinson's disease.

The fine print

Some of the patients treated with SAM stopped treatment due to side effects. This might have influenced the results. Also, the study was funded by Cynapsus Therapeutics and Sunovion, the manufacturer of SAM.

Published By :

The Lancet. Neurology

Date :

Dec 06, 2019

Original Title :

Apomorphine sublingual film for off episodes in Parkinson’s disease: a randomised, double-blind, placebo-controlled phase 3 study.

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