Category: Parkinson’s Disease: Clinical Trials
Objective: Analyze the effect of concomitant trimethobenzamide (TMB) on nausea and vomiting rates in patients with Parkinson’s disease (PD) receiving apomorphine sublingual film (APL) for “OFF” episodes in a long-term safety and efficacy study.
Background: Nausea and vomiting commonly occur with dopaminergic medications. APL is approved for the treatment of “OFF” episodes at doses of 10–30 mg. In a pivotal study in which antiemetics were administered prophylactically, nausea and vomiting were reported in 21% and 4% of APL-treated patients, respectively, during the dose-titration (DT) phase (N=141). The actual need for antiemetics to achieve an effective and tolerable APL dose during DT remains unclear.
Method: An ongoing, open-label, Phase 3 study (NCT02542696) enrolled patients with PD (new [not previously exposed to APL] or rollover from prior APL studies) and “OFF” episodes while on stable PD medications. APL DT occurred in patients who were “OFF” to determine the effective and tolerable dose (10–35 mg; 5-mg increments) that converted them to FULL “ON” within 45 min. Prophylactic use of TMB (300 mg TID) during DT was initially mandatory but was subsequently made optional, to be used at the investigator’s discretion only if clinically warranted. Preliminary results of a post hoc analysis of nausea and vomiting rates are reported descriptively in new US patients who received APL doses of 10–30 mg with and without concomitant TMB during DT.
Results: This analysis (data cut 30Sep2020) evaluated 176 new US patients who received ≥1 dose of APL during the DT phase; 31 (18%) used TMB and 145 (82%) did not. The median (range) duration of TMB use during the DT phase was 16 (1–50) d. Nausea was reported in 52% of patients who received TMB vs 13% in those who did not. Nausea or vomiting was reported in 55% of patients who received TMB vs 13% in those who did not. Overall, 88% of patients successfully titrated to an effective and tolerable dose of APL without the use of TMB during DT.
Conclusion: This preliminary interim analysis of a long-term study suggests that the majority of patients with PD and “OFF” episodes can be titrated to an effective and tolerable dose of apomorphine sublingual film without the need for concomitant antiemetics.
To cite this abstract in AMA style:R. Hauser, S. Factor, W. Ondo, I. Zhang, E. Pappert, B. Navia. Apomorphine Sublingual Film for “OFF” Episodes in Parkinson’s Disease: Impact of Concomitant Antiemetics on Nausea and Vomiting [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/apomorphine-sublingual-film-for-off-episodes-in-parkinsons-disease-impact-of-concomitant-antiemetics-on-nausea-and-vomiting/. Accessed December 7, 2023.
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