Objective: To compare time to onset and magnitude of motor improvement following administration of apomorphine sublingual film (APL-130277; APL) vs levodopa 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 patients with PD and “OFF” episodes receiving levodopa were enrolled into this Phase 3 trial. At screening, patients in a clinically defined “OFF” state were observed for a FULL “ON” response following their normal morning levodopa dose. During open-label titration, patients received 10–35 mg of APL in 5-mg increments per day until a FULL “ON” response was achieved without intolerable side effects. In this post hoc analysis, motor responses following open-label APL and levodopa administration (n=109) were compared by descriptive statistics using the Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score assessed predose, and 15, 30, 45, 60, and 90 minutes postdose.

Results: One hundred nine and 108 patients treated with APL and levodopa, respectively, were analyzed. Predose MDS-UPDRS Part III scores were comparable at screening and titration (43.5 vs 43.1). The magnitude of motor response with APL was ~2-fold higher than with levodopa (-12.6 vs -6.0) at 15 minutes postdose and the observed mean response to APL was greater through 45 minutes postdose. Peak response to APL occurred earlier (45 minutes) than with levodopa (90 minutes), and the magnitude of peak responses was comparable (-26.1 vs -27.9). Responder (defined as a ≥30% decrease in MDS-UPDRS Part III score from predose) rates were 43% vs 18% at 15 minutes and 93% vs 50% at 30 minutes for APL and levodopa, respectively.

Conclusion: APL was associated with an earlier onset of motor improvement and earlier peak response vs levodopa in patients with PD and “OFF” episodes. Responder rates were also higher with APL while the magnitude of peak response was similar between APL and levodopa.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/motor-responses-to-apomorphine-sublingual-film-compared-with-levodopa-in-patients-with-parkinsons-disease-and-off-episodes-post-hoc-analysis-from-a-phase-3-study/