Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations

The US FDA issued decisions on two new drug applications combining an on-body infusion device and an established drug last week. While the decisions went different ways – Supernus Pharmaceuticals, Inc.’s SPN-830 (apomorphine) received a complete response letter, while scPharmaceuticals, Inc.’s Furoscix (furosemide) was approved – the regulatory histories of both products showcase the challenges around manufacturing and device data faced by sponsors of drug-device combination products.

The approval of Furoscix in chronic heart failure patients on 7 October 2022, for example, came more than five years,...