Supernus Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its apomorphine infusion pump (SPN-830) for the continuous treatment of ON-OFF episodes in adults with Parkinson’s disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy.

“We believe the continuous treatment of “OFF” episodes may offer PD patients an important alternative over currently available acute treatments,” said Jack Khattar, President and CEO of Supernus. “Current alternatives to acute treatment often require continuous infusion of levodopa through a gastric tube or surgical intervention such as deep brain stimulation. SPN-830, if approved by the FDA, would offer patients a less invasive and a convenient option in the form of a continuous subcutaneous infusion of apomorphine.”

The NDA for SPN-830 is based on data from an extensive development program, completed by Supernus’ partners, US WorldMeds, and Brittania Pharmaceuticals. The program includes the TOLEDO study, a pivotal Phase III study 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. Both studies included PD subjects with average daily OFF time ≥3 hours. The primary efficacy endpoint in both studies was the change from baseline to Week-12 in mean daily OFF time over 24 hours recorded by the subject in a motor symptom diary. In TOLEDO, the reduction in mean daily OFF time with SPN-830 in comparison with placebo was statistically significant (SPN-830: 2.47 hours, n=53; placebo: 0.58 hours, n= 53; p=0.0025). In the US study, mean daily OFF time decreased from baseline to Week-12 by 3.0 hours (n=94, p<0.0001). Most of the treatment-related adverse events (AEs) were mild or moderate in severity. Infusion site AEs, nausea and dyskinesia were the most frequently reported AEs related to study treatment.