Supernus Pharmaceuticals recently announced that it has resubmitted a New Drug Application (NDA) for its subcutaneous apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations in Parkinson’s Disease (PD). However, as advancement in drug formulations and delivery systems is one of the most rapidly changing areas in PD treatment, SPN-830 is set to enter a fiercely competitive space, says GlobalData, a leading data and analytics company.

Christie Wong, Pharma Analyst at GlobalData, comments: “Although levodopa is a highly effective drug for the treatment of PD, the occurrence of motor fluctuations after a few years of its use, in the form of off-episodes and dyskinesia, creates complications for symptom management. However, the emergence of established dopaminergic drugs in new formulations and modes of delivery could help control motor symptoms over the long term and have positive impacts on patients’ quality of life.”

The recent NDA submission follows a Control Response Letter (CRL) received in October 2022 and a Refusal to File letter in November 2020 for SPN-830. The CRL did not request additional efficacy and safety data. However, additional information was requested on the analysis related to the subcutaneous infusion device and apomorphine across several areas including, but not limited to, labeling, product quality and manufacturing, device performance, and risk analysis.

Wong adds: “Despite the approval hurdles in the US, the continuous subcutaneous infusion of apomorphine has been prescribed as an adjunctive therapy in Europe for the past 20 years and marketed as the Apo-go pump. Key opinion leaders (KOLs) previously interviewed by GlobalData noted that the Apo-go pump is a treatment option for patients that still experience motor complications, despite four or five doses of levodopa during the day.”

However, should SPN-830 receive regulatory approval in the US, it will face stiff competition. SPN-830 will need to compete with AbbVie’s Vyalev/ Produodopa (foslevodopa/foscarbidopa) and NeuroDerm’s ND0612 (levodopa/carbidopa). Both AbbVie and NeuroDerm are racing to the finish line for the US commercialization of the first subcutaneous infusion of levodopa.

When comparing the subcutaneous continuous infusion of apomorphine or levodopa, KOLs stated a preference for levodopa formulations as it is the naturally occurring precursor to dopamine, which is converted in the brain. As such, if approved, Vyalev and ND0612 are expected to be the first-choice subcutaneous delivery systems. GlobalData forecasts that Vyalev and ND0612 will generate $617 million in sales in the US by 2029.

Wong concludes: “Should SPN-830 receive FDA approval, Supernus Pharmaceuticals needs to provide solid marketing to set it apart from competitors in a crowded market.”