Objective: To examine safety and tolerability of apomorphine sublingual film (APL-130277; APL) during maintenance treatment using pooled data from 4 clinical studies in patients with Parkinson’s disease (PD) and “OFF” episodes.

Background: APL was found to be effective and generally well tolerated as an acute, intermittent treatment for “OFF” episodes in patients with PD in a controlled Phase 3 trial.

Method: Adult levodopa-responsive patients with PD and “OFF” episodes exposed to ≥1 dose of APL (10–60 mg/dose) were included in this pooled analysis. Treatment-emergent adverse events (TEAEs) were reported using descriptive statistics. Time to first onset of TEAEs was assessed using Kaplan-Meier analysis.

Results: Among the 285 unique patients in the pooled maintenance treatment phase, median exposure was 85 days (range, 1–283 days) and half received APL for 3 to <9 months. Overall, 75% of patients reported ≥1 TEAE; the most common (≥5%) were nausea (17%), somnolence (7%), dizziness (6%), fall, fatigue, lip swelling, oral mucosal erythema, vomiting, and yawning (5% each). As a category of special interest, oropharyngeal TEAEs were the most common occurring in 29% of patients. Overall, TEAEs led to APL discontinuation in 25% of patients, with oropharyngeal TEAEs being the most common reason for discontinuation. Incidence of TEAEs was similar among patients receiving APL doses <35 mg (75%) and ≥35 mg (73%); the lowest incidence reported was with the 10-mg dose (63%), with no trends observed across higher doses. Time to first TEAE was <1 week for 32% of patients, ≥1–12 weeks for 54% of patients, >12–24 weeks for 22% of patients, and >24 weeks for 7% of patients. The only TEAE with a first onset <1 week and reported by ≥5% of patients was nausea (9%).

Conclusion: During the pooled maintenance treatment phase, APL was well tolerated and observed TEAEs were generally mild to moderate. Safety findings were consistent with known effects of apomorphine and dopamine agonists except for local site reactions associated with sublingual administration.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-apomorphine-sublingual-film-during-maintenance-treatment-in-patients-with-parkinsons-disease-and-off-episodes-a-pooled-analysis/