Objective: To assess the efficacy throughout the day of self-administered apomorphine sublingual film (SL-APO) compared with placebo (PLC) for the treatment of OFF episodes in Parkinson’s disease (PD) patients based on patient-reported home dosing and response diaries from the CTH-300 trial [1].

Background: SL-APO has been shown to be an effective “on-demand” treatment of OFF episodes [1]. Pharmacological tolerance to anti-parkinsonian efficacy of subcutaneous apomorphine after repeated daily dosing has been described before [2,3].

Method: Adult PD patients with >=1 OFF episode per day while on stable doses of levodopa/adjunctive PD medications were randomized to 12 weeks of double-blind treatment with PLC or their effective dose of SL-APO (10–35 mg), determined during open-label titration. Doses were >=2 hours apart, up to 5 times per day. Patients completed a home dosing diary on the 2 days prior to in-clinic visits at weeks 4, 8, and 12 where they recorded the time they self-administered study medication during any OFF episode they chose to treat and the resulting motor status (Full ON/OFF) 30 minutes later. This post-hoc analysis descriptively assessed data from diary entries.

Results: 109 patients (SL-APO:54; PLC:55) were randomized and self-administered a mean of 2.2 and 2.5 daily doses of SL-APO (n=40) and PLC (n=47), respectively. The number of intakes was greatest at 09:00-11:59 [Figure 1]. Full ON response rate with SL-APO ranged from 72% at 06:00-11:59 to 100% at 00:00–02:59 and was consistent at early morning (72% at 06:00–08:59), after-lunch (80% at 12:00–14:59) and bedtime (73% at 21:00–23:59) periods [Figure 2]. In days where at least two administrations were registered, 80% of self-administrations (both groups combined) were 2 to 6 hours apart. Full ON response rate with SL-APO was 86% at 2-3 hours intervals and ranged from 63% to 100% with no clear pattern, while response rates for PLC ranged from 17% to 43% [Figure 3]. Long-term efficacy tolerance was not assessed.

Conclusion: SL-APO self-administration led to a Full ON response in most patients regardless of the time of day and separation in-between dosing. Efficacy of doses following the first daily dose does not seem to be impacted by intake intervals of at least 2 hours.

References: [1] Olanow et al. Lancet Neurol 2020;19(2);135–144
[2] Grandas et al. Neurology 1992;42(7):1287-90
[3] Grandas et al. Clin Neuropharmacol 1989;12(1):14-22

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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-patient-reported-motor-status-response-at-home-throughout-the-day/