biostudies-literatureEspay AJNCATS NIH HHSNIMH NIH HHSNINDS NIH HHSAmneal Pharmaceuticals428-432https://www.ebi.ac.uk/biostudies/studies/S-EPMC10922967biostudies-literatureUnknown39(2)<h4>Background</h4>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.<h4>Objectives</h4>To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.Movement disorders : official journal of the Movement Disorder SocietySafety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study.PMC10922967R01 NS120560K23 MH092735UL1 TR003107Hauser RAThakkar SEspay AJDhall RVisser HBanisadr GCloud LZeitlin LFisher SfalseSafety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study.<h4>Background</h4>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.<h4>Objectives</h4>To evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.2024-01-01T00:00:00Z2024 Feb2026-06-01T18:11:44.866Z2025-04-05T19:19:48.915ZS-EPMC109229673811126710.1002/mds.29685