Efficacy of IPX066, Extended-Release Carbidopa-Levodopa: Subgroup Analysis in Advanced Parkinson’s Disease Patients with Troublesome Dyskinesia (P2.340)

Objective: Evaluate the efficacy of IPX066 in advanced Parkinson’s disease (PD) patients with troublesome dyskinesia Background: IPX066 is an extended-release, multiparticulate formulation of carbidopa-levodopa (CD-LD) that achieves an initial plasma LD peak in about 1 hour and maintains concentrations for 4-5 hours before declining. IPX066 has demonstrated improvements in PD motor symptoms and activities of daily living (ADL) in PD patients. Methods: IPX066 was administered for 13 weeks in a double-blind, parallel-group study vs. immediate-release CD-LD (IR) in advanced PD patients (randomized N=393). This post-hoc analysis examined patients with any reported “on” time with troublesome dyskinesia at study entry, based on patient diaries (IPX066, n=44; IR, n=35). Efficacy measures included patient diaries and Unified Parkinson’s Disease Rating Scale (UPDRS) Parts II (ADL) + III (motor examination). Results: At entry, patients had a mean (SD) “on” time with troublesome dyskinesia of 1.7(1.3) hr and 1.9(1.6) hr, and mean “off” time of 5.3(1.8) hr and 5.5(1.7) hr, for IPX066 and IR groups, respectively. Baseline UPDRS Parts II+III scores were 30.3(14.9) for IPX066 and 34.1(14.8) for IR. At the end of the 13-week treatment period, IPX066 treatment produced a significantly greater improvement in UPDRS Parts II+III scores [−4.9(10.5) points] compared to IR, which worsened by +1.6(10.4) points (P<.001). IPX066 treatment also produced a greater decrease in “off” time [−1.4(2.8) hr] compared to the IR group [−0.7(2.9) hr], although this was not statistically significant (P=.13). Both groups showed less “on” time with troublesome dyskinesia at the end of treatment, −0.4(1.9) hr for IPX066 and −0.8(2.2) hr for IR (P=.40). Conclusions: After treatment with IPX066, advanced PD patients with baseline troublesome dyskinesia demonstrated significantly greater improvement in UPDRS Parts II+III scores and numerically greater improvement in “off” time compared to IR, without increasing “on” time with troublesome dyskinesia. Disclosure: Dr. Dhall has received personal compensation for activities with Impax, Merz Pharma, Acadia, Medtronic, and IO Therapeutics as a consultant and for activities with Impax, UCB Pharma, Teva Neuroscience as a speaker. Dr. Struck has received research support from Impax Laboratories, Inc., Kyowa Kakko Kirin Pharma, Inc., Merz Pharmaceuticals, LLC, and Adamas Pharmaceuticals, Inc. Dr. Rubens has received personal compensation for activities with Impax Laboratories, Inc. Dr. Khanna has received personal compensation for activities with Impax Pharmaceuticals as an employee. Dr. Gupta has received personal compensation for activities with Impax Laboratories as an employee.