Results from a Phase III Clinical Trial for Subcutaneous Infusion of Foslevodopa/Foscarbidopa

Media Contact: Shea Higgins +1 304-633-3396, shiggins@movementdisorders.org 

MILWAUKEE, WI, USA – Continuous subcutaneous infusion (CSCI) of levodopa/carbidopa prodrugs, foslevodopa/foscarbidopa, improved time without dyskinesia in patients with advanced Parkinson’s disease (PD) according to a phase 3 clinical trial released today at the International Congress of Parkinson’s Disease and Movement Disorders® in Madrid, Spain. 

It is well known that long-term use of oral levodopa/carbidopa leads to increased dyskinesia in PD patients. These motor symptoms are thought to be due to the rise and fall of dopamine. Therefore, many investigations have taken place to help treat and prevent the development of levodopa-induced dyskinesia. 

The phase 3 clinical trial designed by Soileau et al. investigated the efficiency and safety of 24-hour CSCI foslevodopa/foscarbidopa, in patients with advanced PD. One hundred forty-one patients were randomized 1:1 to receive CSCI of foslevodopa/foscarbidopa and an oral placebo or CSCI of placebo and an oral dose of levodopa/carbidopa for 12 weeks. Treatment with CSCI of foslevodopa/foscarbidopa produced a greater improvement in time without dyskinesia when measured at week 12. 

Werner Poewe, Professor of Neurology at the Medical University Innsbruck, Austria, responded to this study, “This study is an important milestone in the development of continuous drug-delivery strategies to treat motor fluctuations in PD showing significant increases in ON-time without troublesome dyskinesias using subcutaneous 24-hour infusions of a novel levodopa/carbidopa formulation. The observed effect size is similar to previous studies of levodopa/carbidopa intestinal gel infusions and results on secondary outcomes suggest benefits on sleep and early morning motor function. Local tolerability appears consistent with what is known from continuous subcutaneous apomorphine infusions in PD, suggesting that subcutaneous infusions of levodopa will soon be added to the portfolio of treatment options in PD patients with levodopa-related motor complications.”

Full abstract text: mdsabstracts.org. Reference #: 775
 

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About the 2022 MDS International Congress of Parkinson’s Disease and Movement Disorders®:
The MDS International Congress is the premier annual event to advance the clinical and scientific discipline of Movement Disorders, including Parkinson’s disease. Convening thousands of leading clinicians, scientists and other health professionals from around the globe, the International Congress will introduce more than 1,500 original scientific abstracts and provide a forum for education and collaboration on latest research findings and state-of-the-art treatment options. 

About the International Parkinson and Movement Disorder Society: 
The International Parkinson and Movement Disorder Society (MDS), an international society of over 11,000 clinicians, scientists, and other healthcare professionals, is dedicated to improving patient care through education and research. For more information about MDS, visit www.movementdisorders.org.