Objective: Evaluate the efficacy and safety of P2B001 for different subgroups of patients with early Parkinson’s disease (PD).

Background: P2B001 is an investigational, fixed low-dose, once-daily combination of ER formulations of pramipexole and rasagiline (0.6/0.75mg). We have previously reported that P2B001 provided significantly superior symptomatic efficacy compared with each of its components, as well as comparable efficacy to optimally titrated marketed pramipexole-ER (PramiER), with reduced levels of excessive daytime sleepiness. Here, we evaluated the efficacy and safety of P2B001 in subgroups of patients categorized by age and baseline severity.

Method: This was an international, multicenter, randomized, double-blind, parallel-group study in adult patients (35–80y) with early, untreated PD (<3y from diagnosis) comparing once-daily P2B001 with its individual components and to optimally titrated PramiER (mean dose of 3.2mg). Subgroups were categorized by age (≤median of 66 y vs. >median of 66 y) and baseline severity (≤median of 29 vs. >median of 29 on UPDRS Part II+III scores).

Results: The efficacy and safety profile of P2B001 was not significantly different in younger versus older patients, nor when patients were analyzed by baseline severity. Across all subgroups, P2B001 provided numerically greater symptomatic benefit versus its components, as assessed by Total-UPDRS and statistically significant greater benefit in Activities of Daily Living (UPDRS Part II) versus components. Comparable symptomatic efficacy versus marketed PramiER was confirmed in all subgroups, and P2B001 was consistently superior to PramiER on Epworth Sleepiness Scale scores. There were no apparent differences in the pattern or rates of treatment emergent adverse events or in discontinuation rates by subgroup.

Conclusion: For patients with different ages (younger vs older) and baseline symptom severities, these findings support consistent symptomatic control with P2B001, with comparable efficacy to marketed titrated PramiER, yet with reduced excessive daytime sleepiness.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-efficacy-of-p2b001-low-dose-combination-of-extended-release-pramipexole-and-rasagiline-in-patients-with-early-parkinsons-disease-subgroup-analyses-from-a-randomized-controlled/