Zambon has announced a positive CHMP opinion for Hopledo®, a modified-release levodopa/carbidopa therapy designed for adults with Parkinson’s disease and moderate to severe motor fluctuations. The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization through the European Medicines Agency (EMA).
The recommendation marks an important development in Parkinson’s disease treatment. Moreover, it highlights Zambon’s continued efforts to introduce advanced therapeutic solutions for patients experiencing challenges with existing oral levodopa therapies.
Hopledo® combines immediate-release granules with extended-release pellets in a unique formulation. Therefore, the therapy provides a rapid onset of action while maintaining the levodopa effect for a longer duration. This approach aims to support more consistent symptom management for adults living with Parkinson’s disease.
The CHMP recommendation is supported by findings from the Phase 3 RISE-PD clinical trial. The study compared Hopledo® with immediate-release levodopa/carbidopa (LD/CD) formulations in patients with Parkinson’s disease and moderate to severe motor fluctuations.
According to the trial results, Hopledo® demonstrated a significant improvement in Good ON time compared with immediate-release LD/CD. Additionally, the therapy achieved these outcomes with fewer daily doses and showed a comparable safety profile.
Advancing Parkinson’s Disease Treatment With Modified-Release Therapy
Parkinson’s disease remains one of the fastest-growing neurological conditions worldwide, according to the World Health Organization. As the disease progresses, more than 80% of patients experience motor fluctuations despite available treatments.
Therefore, the need for improved Parkinson’s disease therapies continues to increase. Hopledo® is designed as a first-in-class oral modified-release formulation of LD/CD to address these treatment challenges.
The therapy helps extend levodopa benefits while reducing fluctuations between “Good On” and “Off” periods. Furthermore, the simplified dosing approach may help patients achieve more stable symptom control.
In 2024, Zambon entered an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom, and Switzerland. Previously known as IPX203, Hopledo® has already received approval and is marketed in the United States under the brand name CREXONT®.
This existing regulatory and commercial experience provides further support as the therapy moves toward European approval.
“In Parkinson’s disease treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing “Off” time, and simplifying dosing. Hopledo ability to extend “Good On” time with fewer daily doses offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects,” said Prof. Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and of the Parkinson’s Disease Research Centre.
“The CHMP positive opinion represents an important step towards expending access to this important therapy to patients in Europe. As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting “Good On” time with fewer daily doses. This achievement underscores Zambon’s leadership in Parkinson’s disease and our unwavering commitment to more than one million people currently living with Parkinson’s disease in the EU,” said Mathias Knecht, M.D., Chief Medical Officer Innovative Therapies, Zambon.
Subject to approval from the European Commission, Zambon expects to begin the phased introduction of Hopledo® across European markets from October 2026.
Meanwhile, the company continues working with healthcare authorities and industry stakeholders. The goal is to support timely access to this new Parkinson’s disease treatment option for patients who continue experiencing motor fluctuations despite current oral therapies.
About the RISE-PD Phase 3 Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the safety and effectiveness of IPX203 compared with immediate-release LD/CD therapy.
The primary objective of the study measured changes from baseline in “Good On” time in hours per day after the double-blind treatment period. The assessment was conducted at Week 20 or early termination.
Additionally, secondary endpoints evaluated changes in “Off” time, patient improvement scores through Patients’ Global Impression of Change (PGI-C), and Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) outcomes.
The trial included 506 patients who received a Parkinson’s disease diagnosis at age 40 or older. The findings supported Hopledo® as a potential advancement in managing Parkinson’s disease motor fluctuations.
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News Source: Businesswire.com
