The Parkinson’s disease combination drug Hopledo (levodopa–carbidopa, Zambon S.p.A.) has received a positive opinion by the European Medicines Agency (EMA).
Hopledo’s components, levodopa and carbidopa, are established Parkinson’s drugs that are often combined. The new formulation consists of modified-release hard capsules that contain both immediate-release granules and extended-release beads.
The immediate-release granules consist of levodopa and carbidopa with a disintegrant polymer, allowing for rapid dissolution.
The extended-release beads consist of levodopa coated with a sustained-release polymer, allowing for prolonged release of the dose; a mucoadhesive polymer to keep the beads adherent to the area of absorption longer; and an enteric coating to prevent the beads from disintegrating too early in the stomach.
Sustained release of the drug prolongs pharmaceutical action, minimizes fluctuations in serum concentration, reduces dosing frequency, and improves patient compliance.
Parkinson’s disease is due to a gradual reduction in the brain’s ability to produce dopamine, the neurotransmitter controlling movement and balance. The most common symptoms are tremor, muscle rigidity, slowed movement, and mood changes. Many of those affected lose their sense of smell and develop a fixed facial expression.
Levodopa is the usual first line drug and most effective treatment for Parkinson’s disease movement symptoms. It is converted to dopamine in the brain. Given alone, it frequently causes nausea and vomiting, but this is substantially lessened or eliminated when it is combined with carbidopa.
Parkinson’s disease affects about 180 per 100,000 people in Europe, higher than the global estimated prevalence of 151 per 100,000 people. This may be partly because of the relatively older age of European populations. Numbers affected have more than doubled in the last 30 years and are expected to double again by 2030.
The EMA recommended granting marketing authorization for Hopledo for the treatment of adult patients with Parkinson’s disease and moderate-to-severe motor fluctuations who have not been sufficiently stabilized with oral levodopa plus dopa decarboxylase inhibitor-based treatment regimens.
Common side effects of combined preparations include nausea, vomiting, loss of appetite, hypotension, confusion, hallucinations, and dyskinesia. Seizures linked to low vitamin B6 (pyridoxine) levels have been reported, especially at higher doses.
Detailed recommendations for the use of Hopledo will be described in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
