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AbbVie Launches Parkinson’s Treatment Produodopa in EU Markets

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AbbVie has introduced Produodopa (foslevodopa/foscarbidopa) in the European Union, marking a significant advancement in the treatment of advanced Parkinson’s disease (PD). This new therapy is specifically targeted for Parkinson’s disease patients experiencing severe motor fluctuations and dyskinesia. Produodopa represents the first 24-hour continuous subcutaneous infusion therapy utilizing levodopa, aimed at individuals with advanced PD whose symptoms are not adequately controlled by current treatments.

The unique design of Produodopa ensures a continuous delivery of levodopa, striving to prolong the period of symptom control, often referred to as “On” time. This extended duration of symptom management is crucial for improving the quality of life for patients with advanced PD.

Parkinson's disease

Positive Clinical Trials Propel EU Marketing Authorization for Produodopa in Parkinson’s Treatment

The marketing authorization of Produodopa in 2022 was underpinned by the positive results of three pivotal studies. The M15-741 study, a Phase III trial lasting 12 months, was crucial in assessing Produodopa’s long-term tolerability, safety, and effectiveness. Additionally, the M15-736 study, another critical Phase III trial conducted over 12 weeks, was instrumental in comparing Produodopa’s safety and efficacy against oral levodopa/carbidopa.

Results from the M15-741 study revealed a favorable benefit/risk profile for Produodopa, underscoring its potential as a game-changing therapy for patients with advanced PD. This breakthrough treatment offers new hope for those struggling with severe motor fluctuations and dyskinesia, providing a novel option to manage their symptoms more effectively.

 

Resource: Pharmaceutical Business Review, January 10, 2024

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