Phase III results from RISE-PD clinical study of IPX 203 in Parkinson’s disease published in JAMA Neurology

The study met its primary and secondary endpoints finding that IPX 203 provided more hours of “Good On” time per day, less “Off” time per day, and more “Good On” time per dose than optimized IR CD/LD, even when dosed less frequently. “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. The manuscript titled, “IPX 203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease,” was published online on August 14, 2023.

RISE-PD was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase III clinical trial. A total of 630 patients (mean age 66.5 years; 62.9% men) were enrolled and 506 patients were randomly assigned to receive IPX 203 or immediate-release carbidopa-levodopa. The results published in JAMA Neurology show that treatment with IPX203 demonstrated statistically significant improvement in daily “Good On” time with fewer doses of IPX 203 compared with immediate-release carbidopa-levodopa (least squares mean, 0.53 hours; 95% CI, 0.09-0.97), with IPX 203 dosed a mean three times per day vs 5 times per day for immediate-release carbidopa-levodopa.

Additionally, “Good On” time per dose increased by 1.55 hours with IPX 203 compared with immediate-release carbidopa-levodopa (95% CI, 1.37-1.73). IPX 203 was well tolerated. The most frequently reported TEAEs among patients treated with IPX 203 were nausea (11 [4.3%]), anxiety (7 [2.7%]), and dizziness (6 [2.3%]). The most frequently reported TEAEs among patients treated with IR CD-LD were fall (9 [3.6%]), urinary tract infection (8 [3.2%]), and back pain (7 [2.8%]).

See: "IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson DiseaseThe RISE-PD Randomized Clinical Trial" Robert A. Hauser et al. JAMA Neurol. Published online August 14, 2023. doi:10.1001/jamaneurol.2023.2679