The NDA for SPN-830 is based on data from an extensive development program, completed by Supernus' partners, US WorldMeds, LLC and Brittania Pharmaceuticals Ltd. The program includes the TOLEDO study, a pivotal Phase III study (conducted in Europe, ref. Katzenschlager et al, Lancet Neurology 2018; 17: 749–59) and a supportive safety and efficacy study (conducted in the US). TOLEDO was a Phase III, multi-center, double-blind, placebo-controlled study that investigated the efficacy and safety of apomorphine subcutaneous infusion in PD subjects whose motor fluctuations were not adequately controlled on optimized treatment. The US study is an open label study which investigated the safety and effectiveness of SPN-830. The study eligibility criteria, apomorphine administration and dosing, study schedule, and efficacy and safety measures in both studies were similar.