Objective: Evaluate efficacy and patient satisfaction associated with 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 efficacy of SL-APO vs SC-APO.

Method: An open-label, randomized, crossover study consisting of titration (Part A) and treatment (Part B) phases using a blinded rater 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. The primary endpoint was change from predose to 90 min postdose in MDS-UPDRS Part III score at wk 4 in each treatment period (data were also collected at 15, 30, 60, and 120 min postdose). Secondary endpoints included the proportion of patients with FULL ON at 30 and 90 min postdose (durability of response; assessed by investigator and patient) and patient preference. Primary and secondary endpoints were assessed hierarchically.

Results: Overall, 113 and 74 patients were randomized in Part A and B, respectively. Efficacy of SL-APO and SC-APO in change from predose to 90 min postdose in MDS-UPDRS Part III scores at wk 4 was similar (‒13.5 vs ‒13.8; P=NS); efficacy was also similar at 15 min postdose (SL-APO: ‒11.5; SC-APO: ‒14.7) and at all other time points. Durability of response at wk 4 for SL-APO vs SC-APO was similar as assessed by investigator (12% vs 11%), but differed as assessed by patient (14% vs 8%). SL-APO was preferred over SC-APO by 72% of patients (P<0.001).

Conclusion: In this open-label, randomized, crossover study, efficacy of SL-APO and SC-APO for the treatment of OFF episodes in patients with PD was similar at all time points through 120 min postdose. Patients reported an overall preference for SL-APO over SC-APO at study endpoint.

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