Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study
- PMID: 38111267
- PMCID: PMC10922967
- DOI: 10.1002/mds.29685
Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study
Abstract
Background: IPX203 is a novel oral extended-release formulation of carbidopa/levodopa (CD/LD) developed to address the short half-life of immediate-release CD/LD. In the phase 3 RISE-PD trial, IPX203 significantly improved "Good On" time in patients with Parkinson's disease compared with immediate-release CD/LD.
Objectives: To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.
Methods: This 9-month extension enrolled patients who completed the randomized, double-blind trial. Key efficacy endpoints included Movement Disorder Society-Unified Parkinson's Disease Rating Scale and Patient and Clinical Global Impression scores. Adverse events (AEs) were recorded.
Results: Improvements in efficacy were maintained and dosing frequency and total daily dose remained stable through the trial. A total of 52.7% of patients experienced ≥1 treatment-emergent AE, mostly mild or moderate and occurred within the first 90 days of treatment.
Conclusions: In this phase 3 open-label extension, IPX203 exhibited a favorable safety and tolerability profile and sustained efficacy of comparable magnitude to the end of the double-blind study. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Keywords: extended release; levodopa; motor fluctuations; parkinson's diseases.
© 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Conflict of interest statement
Financial Disclosure/Conflict of Interest:
Alberto J. Espay is a study investigator for, has received honoraria and travel support from, and serves as a consultant and on the Speakers’ Bureau for Amneal.
Robert A. Hauser is a study investigator for, has received honoraria and travel support from, and serves as a consultant and on the Speakers’ Bureau for Amneal.
Rohit Dhall is a study investigator for Amneal.
Sandeep Thakkar is a study investigator for and has received honoraria and travel support from Amneal.
Leslie Cloud is a study investigator for Amneal.
Leonid Zeitlin is a consultant for Quartesian, LLC, a company that provides clinical data services to Amneal.
Ghazal Banisadr, Stanley Fisher, and Hester Visser are employees of Amneal and may hold stock or ownership interest in Amneal.
References
-
- LeWitt PA. Levodopa therapy for Parkinson’s disease: pharmacokinetics and pharmacodynamics. Mov Disord 2015; 30(1): 64–72. - PubMed
-
- Stocchi F The levodopa wearing-off phenomenon in Parkinson’s disease: pharmacokinetic considerations. Expert Opin Pharmacother 2006; 7(10): 1399–1407. - PubMed
-
- Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord 2008; 23(15): 2129–2170. - PubMed
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical
Research Materials