Date: Thursday, June 8, 2017
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
To determine the dose of APL-130277 required by each patient with Parkinson’s Disease (PD) to turn from OFF to Full ON. This dose is to be utilized in the Phase 3 double-blind, placebo-controlled trial (Maintenance Treatment Phase (MTP).
Patients with Parkinson’s disease (PD) frequently develop problematic OFF episodes despite optimization of therapies. APL-130277 (apomorphine) is administered sublingually and being studied for OFF episodes.
The open-label dose titration phase (DTP) was conducted to determine the appropriate dose of APL-130277 for each patient in the double-blind, placebo-controlled MTP. Patients with PD who had well-defined early AM OFF episodes and total OFF time >2hours/day were enrolled. Patients were evaluated in the OFF period. The titration sequence for APL-130277 was 10mg, 15mg, 20mg, 25mg and 30mg. After the dose was administered the MDS-UPDRS Part III was obtained at 15, 30, 45, 60 and 90 minutes. Patients who responded with a full ON within 45 mins could move to the MTP. Patients who did not achieve a full ON returned to the clinic 3 days (+/-2d) for the next titration dose (i.e., 15mg). The process was repeated until patients achieved a full ON within 45 mins or reached 35mg.
Preliminary efficacy data are available for the 76 patients (46 men, 30 women) who have completed the DTP and responded to treatment. The median MDS-UPDRS Part III (OFF) was 41.9. The mean number of daily OFF episodes was 3.7. The median dose to turn patients fully ON was 20 mg. 81% of patients who entered the DTP turned fully ON with APL-130277. For responders, the onset of clinical benefit (patient assessment) was 5-12 minutes. 22% of patients turned fully ON by 15 minutes and 59% by 30 minutes. At 30 and 90 minutes there was a 22 and 16-point improvement in the MDS-UPDRS Part III, respectively.
In this preliminary analysis of this study, APL-130277 provided rapid improvement in patients with PD in the OFF state. The onset of clinical benefit appeared within 5-12 mins and was sustained over 90 mins.
To be presented at: 1st Pan American Parkinson’s Disease and Movement Disorders Congress (February 24-26, 2017; Miami, FL)
To cite this abstract in AMA style:R. Hauser, S. Isaacson, A. Espay, R. Pahwa, D. Truong, E. Pappert, P. Gardzinski, B. Dzyngel, A. Agro, H. Fernandez. Efficacy of sublingual apomorphine film (APL-130277) for the treatment of OFF episodes in patients with Parkinson’s disease: results from the Phase 3 study dose-titration phase [abstract]. Mov Disord. 2017; 32 (suppl 2). http://www.mdsabstracts.org/abstract/efficacy-of-sublingual-apomorphine-film-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease-results-from-the-phase-3-study-dose-titration-phase/. Accessed November 22, 2017.
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MDS Abstracts - http://www.mdsabstracts.org/abstract/efficacy-of-sublingual-apomorphine-film-apl-130277-for-the-treatment-of-off-episodes-in-patients-with-parkinsons-disease-results-from-the-phase-3-study-dose-titration-phase/