To evaluate the impact of CREXONT^® (IPX203, ER CD-LD) twice daily (BID) on “Good On” time in Parkinson’s disease patients requiring <500 mg/day immediate-release (IR) carbidopa-levodopa (CD-LD).

RISE-PD, a phase 3 randomized, double-blind trial, demonstrated CREXONT significantly increased “Good On” time versus IR CD-LD with less frequent dosing (mean 3x vs. 5x per day for IR CD-LD). Patients with lower levodopa requirements (<500mg/day of IR CD-LD) were initiated on BID CREXONT, offering insight into outcomes with a simplified regimen.

Patients from RISE-PD were stratified by dosing frequency across timepoints. Changes in daily “Good On” time following conversion from optimized IR CD-LD to CREXONT were analyzed and compared between subgroups, focusing on those initiated on BID dosing and remained on BID at the end of study.

Of 449 patients who completed the study, 54 (10.9%) were initiated on CREXONT BID at the start of the dose-conversion from optimized IR CD-LD. 31 (57%) successfully maintained stable BID dosing throughout the dose-conversion period. The strongest predictor of a need for adjustment was dosing frequency on optimized IR CD-LD, which was on average 4.03 (SEM=0.03) for patients on stable BID vs. 4.43 (SEM=0.12, p=0.0007) for patients that needed dose adjustment. By the end of the double-blind phase, patients who remained on BID dosing achieved an average gain of 2.0 hours of daily “Good On” time (SEM=0.51; p=0.042), significantly greater than the overall population gain of 0.89 hours (SEM=0.22; p=0.008). Patients who required increases in dosing frequency after starting BID gained 0.85 hours (SEM=0.22; p=0.58), an increase comparable to the broader cohort.

In patients with motor fluctuations with lower levodopa needs, CREXONT BID provided a robust and clinically meaningful increase in “Good On” time. These findings support a simplified regimen with CREXONT that may reduce pill burden while maintaining strong efficacy in these PD patients.