IPX203 provides more relief in fewer daily doses for Parkinson’s with motor fluctuations
Key takeaways:
- Study examined safety and efficacy of IPX203 and immediate-release carbidopa/levodopa over 20 weeks.
- IPX203 led to 1.55 more hours of ‘good’ on-time per dose compared with CD/LD.
An oral, extended-release therapeutic provided more ‘good’ on-time in fewer daily doses compared with immediate-release carbidopa/levodopa in Parkinson’s disease with motor fluctuations, according to research presented in JAMA Neurology.
“IPX203, a new oral, extended-release carbidopa-levodopa capsule was developed to address the short plasma half-life and limited absorption window for [levodopa],” Robert A. Hauser, MD, MBA, of the University of South Florida Parkinson’s Disease and Movement Disorders Center, and colleagues wrote.
Researchers aimed to assess safety and efficacy of novel therapeutic IPX203 compared with immediate-release carbidopa-levodopa in those with Parkinson’s disease and motor fluctuations.
They conducted the RISE-PD study, a 20-week, randomized, double-blind active-controlled, phase 3 clinical trial at 105 academic and clinical centers throughout the United States and Europe. A total of 630 patients (mean age 66.5 years; 62.9% men) were enrolled with 506 participants who were randomly assigned 1:1 to receive either IPX203 (n=256) or immediate-release carbidopa-levodopa (n=250) following a 3-week open-label, immediate-release carbidopa-levodopa dose adjustment. The study’s primary endpoint was mean change in daily good on-time (without troublesome dyskinesia) from baseline to the end of the 13-week double-blind treatment period.
According to results, treatment with IPX203 demonstrated statistically significant improvement in daily “good” on-time for fewer doses of IPX203 compared with immediate-release carbidopa-levodopa (least squares mean, 0.53 hours; 95% CI, 0.09-0.97), with IPX203 dosed a mean three times per day compared with immediate-release carbidopa-levodopa dosed five times per day.
Data additionally showed that “good” on-time per dose increased by nearly 2 hours with IPX203 compared with immediate-release carbidopa-levodopa (95% CI, 1.37-1.73). IPX203 was also well tolerated, with the most common adverse events in the double-blind phase (IPX203 vs. immediate-release carbidopa-levodopa) being nausea (4.3% vs. 0.8%) and anxiety (2.7% vs 0%).
“These results suggest that IPX203 may be useful in patients with motor fluctuations to provide more sustained benefit throughout the day,” Hauser and colleagues wrote.