Session Information
Date: Tuesday, June 21, 2016
Session Title: Parkinson's disease: Pathophysiology
Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Evaluate if any differences exist in the efficacy of APL-130277 doses to turn a patient with Parkinson’s disease (PD) from OFF to fully ON based upon subgroup analyses.
Background: APL-130277 is a sublingual film being studied in Phase 3 trials to rapidly turn patients ON from OFF episodes by delivering apomorphine via the oral mucosa.
Methods: PD patients with at least one OFF episode/day and = or > 2 hours of daily OFF time were included. Patients were dosed in the OFF state, starting with APL-130277 10 mg and, if needed, increased in 5 mg increments until fully ON, to a maximum of 30 mg. Changes in MDS-UPDRS Part III were evaluated.
Results: Of the 19 patients dosed, 15 converted from OFF to ON with APL-130277. When evaluating patients by number of OFF episodes, age at time of study, levodopa dose, number of classes of PD medications, and years of OFF episodes, the percentage of patients turning ON with APL-130277 and the percent MDS-UPDRS Part III improvement were similar among groups.
| Characteristic | n | % of Patents Fully ON 30 Minutes After Dosing | % Change in MDS-UPDRS Part III 30 Minutes After Dosing | |
| OFF Episodes, # | < 4 | 7 | 100 | -37.7 |
| = or > 4 | 12 | 67 | -32.5 | |
| Age, years | < 65 | 12 | 83 | -40.2 |
| = or > 65 | 7 | 71 | -24.5 | |
| Levodopa dose, mg | < or = 600 | 9 | 89 | -36.6 |
| > 600 | 10 | 70 | -32.5 | |
| Number of PD Daily Medication Classes | < 3 | 7 | 57 | -33.3 |
| 3 | 6 | 80 | -31.5 | |
| > 3 | 7 | 100 | -37.7 | |
| Years of OFF Episodes | < or = 5 | 12 | 83 | -36.1 |
| > 5 | 7 | 71 | -31.7 |
Conclusions: APL-130277 converts patients with PD from OFF to fully ON regardless of patient demographics or disease characteristics.
Presented, in part, at the XXI World Congress on Parkinson’s disease and Related Disorders (Dec 6-9, 2015; Milan, Italy). Dubow J, Dzyngel B, Bilbault T, Giovinazzo A, Agro A. The effects of sublingual apomorphine (APL-130277) by disease severity on the acute reversal of OFF episodes in Parkinson’s disease patients. ID 37.
To cite this abstract in AMA style:
H. Shill, E.J. Pappert, A. Agro, B. Dzyngel, T. Bilbault, R. Hauser, S. Isaacson. APL-130277 is a sublingual film being studied in phase 3 trials to rapidly turn patients ON from OFF episodes by delivering apomorphine via the oral mucosa [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/apl-130277-is-a-sublingual-film-being-studied-in-phase-3-trials-to-rapidly-turn-patients-on-from-off-episodes-by-delivering-apomorphine-via-the-oral-mucosa/. Accessed November 21, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/apl-130277-is-a-sublingual-film-being-studied-in-phase-3-trials-to-rapidly-turn-patients-on-from-off-episodes-by-delivering-apomorphine-via-the-oral-mucosa/