Objective: Analyze effect of concomitant antiemetics and dopamine agonists (DA) on nausea and vomiting (N/V) in patients receiving apomorphine sublingual film (APL-130277; APL) for on-demand treatment of “OFF” episodes in Parkinson’s disease (PD).

Background: In a pivotal study, APL significantly improved MDS-UPDRS Part III score at wk 12 (LSM difference from placebo, –7.6; P=0.0002); an ongoing open-label, Phase 3 study (NCT02542696) supports long-term efficacy and safety.

Method: In the long-term study, patients with PD and “OFF” episodes on stable PD medications (eg, oral/transdermal DA) were enrolled and treated with APL while in a practically defined “OFF” state (optimized dose [10–35 mg] resulting in FULL “ON” within 45 minutes) during open-label dose titration (DT) and self-administered their optimized APL dose for up to 5 “OFF” episodes/d in the long-term safety (LTS) phase. Antiemetics (trimethobenzamide 300 mg TID or domperidone 10 mg BID) were permitted for those who developed N/V. Interim results of N/V TEAEs during both phases (up to 48 wks of LTS) are reported descriptively.

Results: In the DT phase, 425 patients received ≥1 APL dose; 226 (53%) used an antiemetic (median APL exposure=22 d); 199 (47%) did not (exposure=21 d). For antiemetic vs no antiemetic, nausea (14% vs 16%) and vomiting (3% vs 1%) were similar, as was nausea leading to D/C (2% vs 2%); vomiting leading to D/C was not observed. In the LTS phase, 345 received ≥1 APL dose; 188 (54%) used an antiemetic (exposure=166 d) and 157 (46%) did not (exposure=103 d). Nausea (19% vs 20%) and vomiting (4% vs 3%) were similar, as was vomiting leading to D/C (2% vs 1%); nausea leading to D/C was higher (7% vs 3%). In the DT phase, 254 (60%) used other DA (exposure=23 d) and 171 (40%) did not (exposure=18 d). For DA vs no DA, rates of nausea were 7% vs 26% and vomiting was <1% vs 4%. Nausea leading to D/C was reported for no DA only (5%). In the LTS phase, 217 (63%) used DA (exposure=166 d) and 128 (37%) did not (exposure=93 d). Nausea (13% vs 31%), vomiting (2% vs 7%), and nausea leading to D/C (1% vs 11%) were less frequent for DA; vomiting leading to D/C (1% vs 2%) was similar.

Conclusion: Interim data suggest that patients using apomorphine sublingual film may not require antiemetics, and patients using other DA (vs no DA) have lower incidence of N/V TEAEs.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-on-demand-treatment-of-off-episodes-in-patients-with-parkinsons-disease-impact-of-concomitant-antiemetics-and-dopamine-agonists-on-nausea-an/