Objective: To compare the duration of continuous “On” without troublesome dyskinesia (“Good On”) intervals and number of motor fluctuations per day in Parkinson’s disease (PD) patients treated with IPX203 vs IR CD-LD.

Background: IPX203, an extended-release oral CD-LD formulation, was evaluated vs IR CD-LD in PD patients with motor fluctuations in a Phase 3 study. IPX203 showed statistically significant improvement in “Good On” time per day and “Good On” time per dose compared to IR CD-LD.

Method: RISE-PD was a randomized, double-blind, active-controlled, Phase 3 trial evaluating the safety and efficacy of IPX203 vs IR CD-LD in PD patients with motor fluctuations. All patients underwent 3 weeks of IR CD-LD dose adjustment, and a 4-week, open-label conversion to IPX203, followed by randomization (at Visit 4/baseline) to a 13-week double-blind treatment with either IR CD-LD or IPX203. The average duration of continuous “Good On” intervals and average daily number of motor fluctuations (defined as a change from “Off” to “On” state or from “On” to “Off” state) were assessed using data from patient PD diaries.

Results: Four hundred ninety-five subjects who successfully completed conversion from IR CD-LD to IPX203 were randomized into the double-blind period. Subjects on IPX203 showed greater improvement in average duration of continuous “Good On” interval from Visit 4/baseline to Visit 7/end of study (EOS) when compared with those on IR CD-LD (mean change from Visit 4/baseline to Visit 7/EOS for continuous “Good On” interval [hours]; IPX203: -0.07 and IR CD-LD: -0.98, p=0.0002). Subjects on IPX203 showed a greater improvement in the average number of motor fluctuations per day from Visit 4/baseline to Visit 7/EOS when compared with those on IR CD-LD (mean change from Visit 4/baseline to Visit 7/EOS; IPX203: 0.17 and IR CD-LD: 1.47, p<0.0001). At EOS, mean number of motor fluctuations per day was 3.75 for IPX203 and 5.14 for IR CD-LD.

Conclusion: Compared with IR CD-LD, IPX203 provided longer duration of continuous “Good On” intervals and decreased number of daily motor fluctuations. This may allow PD patients to better plan and engage in their daily activities.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/duration-of-continuous-good-on-intervals-and-number-of-motor-fluctuations-after-treatment-with-ipx203-vs-immediate-release-carbidopa-levodopa-in-parkinsons-disease-patients/