Objective: Evaluate safety and tolerability of apomorphine sublingual film (SL-APO) vs subcutaneous apomorphine (SC-APO) for the treatment of OFF episodes in patients with Parkinson’s disease (PD).

Background: Sublingual and subcutaneous apomorphine formulations have been used for the treatment of OFF episodes. To date, no studies have compared the safety of SL-APO vs SC-APO.

Method: An open-label, randomized, crossover study consisting of titration (Part A) and treatment (Part B) phases assessed SL-APO vs SC-APO in patients with PD and OFF episodes. In Part A, both medications were titrated in all patients in a randomly assigned order (SL-APO: 10‒30 mg, 5-mg increments [partial at-home titration]; SC-APO: 2‒6 mg, 1-mg increments [in-clinic titration]) to determine the dose that provided a FULL ON within 30 min. Patients completed a 3‒7 d washout between titrations and at the end of Part A. In Part B, patients were randomized 1:1 to 4 wk of treatment with their optimized dose of SL-APO or SC-APO for up to 5 OFF episodes/d, followed by a washout and 4 wk of crossover treatment. Safety endpoints included overall adverse events (AEs), drug-related AEs, serious AEs (SAEs), and AEs leading to discontinuation.

Results: In Part A (SL-APO, n=102; SC-APO, n=97), rates of overall AEs, drug-related AEs, SAEs, and AEs leading to discontinuation were generally comparable between SL-APO and SC-APO. In Part B (SL-APO, n=71; SC-APO, n=70), rates of overall AEs (54% vs 69%) and drug-related AEs (41% vs 57%) were lower for SL-APO vs SC-APO, while AEs leading to discontinuation (6% vs 3%) were comparable between the 2 formulations. There was no apparent dose-dependent relationship for AEs overall. The most common AEs (≥5%) were generally similar between treatments (Table 1). Higher rates of nausea were observed with SL-APO (31%) vs SC-APO (23%) in Part A, but rates were comparable (14% vs 16%) in Part B. Rates of dyskinesia were comparable for SL-APO vs SC-APO in Part A (8% vs 7%), but lower for SL-APO (11%) vs SC-APO (20%) in Part B. Expected route of administration-related differences in AEs were observed.

Conclusion: In this open-label, randomized, crossover study, SL-APO and SC-APO were generally well tolerated in patients with PD and OFF episodes. The safety profiles of SL-APO and SC-APO were generally comparable and no new safety signals were identified.[table1]

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-apomorphine-sublingual-film-and-subcutaneous-apomorphine-for-the-treatment-of-off-episodes-in-parkinsons-disease/