RISE-PD Study of IPX-203 in Parkinson Disease: Robert A. Hauser, MD, MBA

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“[With] the primary outcome measure of the increase in good ON time, many people look at it and say, ‘Well 0.53 hours is a half an hour increase in ON time, it’s not that much per day.’ But you have to keep in mind that patients received IPX-203 three times per day, compared to IR CD-LD an average of five times per day.”

Robert A. Hauser, MD, MBA, professor of neurology, and director, Parkinson’s Disease and Movement Disorder Center, University of South Florida, presented data from a pair of posters from the RISE-PD trial (NCT03670953) on an investigational oral extended-release (ER) formulation of carbidopa-levodopa (CD-LD), IPX-203 (Amneal Pharmaceuticals) at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington.^1,2

In the first poster, overall, the data showed promise, with IPX-203 meeting the primary end point by showing statistically significant improvement in good ON time compared with immediate-release (IR) CD-LD (0.53 hours; P = .0194) in a cohort of 506 patients with Parkinson disease (PD) who experience motor fluctuations.1 The secondary end point—change from baseline in OFF time—displayed similar results, with IPX203 treatment resulting in significantly less OFF time compared with IR CD-LD (–0.48 hours; P = .0252).¹

The second poster, a post hoc analysis of the RISE-PD data, demonstrated similar promise in a modified intent-to-treat population (n = 495). At the end-of-study visit, those in the IPX-203 group (n = 249) had 3.76 hours of good ON time per dose, compared with 2.21 hours for those on IR CD-LD (P <.0001).²

In conversation with NeurologyLive^®, Hauser detailed some of these data and offered his perspectives on their implications. Specifically, he spoke to the design of RISE-PD and the insights that he and his coinvestigators gained from the clinical trial.

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REFERENCES
1. Hauser RA, Espay AJ, LeWitt P, et al. A Phase 3 Trial of IPX203 vs CD-LD IR in Parkinson’s Disease Patients with Motor Fluctuations (RISE-PD). Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual. Abstract 001225.
2. Hauser RA, Fernandez HH, Klos K, et al. Duration of Benefit Per Dose: Post Hoc Analysis of ”Good On” Time Per Dose for IPX203 vs CD-LD IR in the RISE-PD Phase 3 Trial. Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual. Abstract 001231.