The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion for Onerji (levodopa/carbidopa, Tanabe Pharma) for the treatment of adults with advanced Parkinson's disease.

In granting a marketing authorization, the EMA highlighted that Onerji, administered by continuous subcutaneous infusion, offers patients the benefits of increasing levodopa plasma concentrations and providing relief of motor fluctuations. 

Onerji should be used in adults with the advanced form of the disease when motor fluctuations are not sufficiently controlled by oral anti-Parkinson medicinal products.

Motor fluctuations emerge in approximately 40% of people with Parkinson’s after 4-6 years of disease, with rates rising to 54.3% within 5 years and 100% within 10 years.

Patients receiving oral levodopa/carbidopa often experience wearing-off effects. To mitigate this, higher “off‐time” doses may be added, but higher peak dopamine levels may worsen adverse effects, especially dyskinesia. 

The continuous infusion method aims to reduce motor complications and improve overall symptom control for patients with advanced Parkinson’s disease. The continuous delivery of levodopa/carbidopa helps maintain stable plasma drug levels and addresses the limitations of oral medications. 

A recent systematic review and meta ‐ analysis of subcutaneous levodopa in Parkinson's disease found that subcutaneous infusion therapies produced a clinically and statistically significant reduction in the duration of off ‐ time experienced by patients compared with oral levodopa/carbidopa.

Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted into dopamine in the brain, helping to reduce Parkinson’s disease symptoms. Carbidopa prevents levodopa from being broken down to soon, thus enabling more levodopa to reach the brain, thereby helping it to work better. In addition, this also reduces side effects allowing levodopa to be used more effectively.

The treatment is administered as a continuous subcutaneous infusion and should only be used with the Yurway Delivery System or the Crono Twin ND pump, the EMA said. 

Onerji will be available as a 60 mg (levodopa) + 7.5 mg (carbidopa) per mL solution for infusion. 

The most common side effects of the treatment are infusion site reactions, including nodule, hematoma, pain, infection, erythema and eschar, and dyskinesia.

Rob Hicks is a retired National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications. He is based in the United Kingdom.