The treatment is indicated for use in PD patients experiencing severe motor fluctuations and hyperkinesia or dyskinesia.
This marks the introduction of the first 24-hour continuous subcutaneous infusion therapy using levodopa for individuals with advanced PD whose symptoms are not adequately controlled by existing treatments.
Produodopa is designed to provide a continuous delivery of levodopa, aiming to extend the duration of symptom control, known as “On” time.
Produodopa received a marketing authorisation through the Decentralized Procedure in the third quarter of 2022, following the positive outcomes of three supporting studies.
The M15-741 study, a Phase III 12-month open-label trial, assessed the long-term tolerability, safety, and efficacy of Produodopa.
Another Phase III 12-week trial, M15-736, compared the safety and efficacy of Produodopa to oral doses of levodopa/carbidopa.
Results from the M15-741 study indicated a favourable benefit/risk profile for Produodopa.
Additionally, Produodopa demonstrated sustained improvements in “Off” time and “On” time without dyskinesia, as well as morning akinesia.
The majority of adverse events (AEs) reported were non-serious and of mild or moderate severity in nature.
Reactions at infusion site, falls, hallucinations, and anxiety were the most frequently seen AEs.
AbbVie Global Therapeutics senior vice-president and chief medical officer Roopal Thakkar said: “People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled.
“This approval is an example of our unwavering commitment to this community by developing new, transformative therapeutic options for people experiencing advanced Parkinson’s disease, their families, and care partners.”