FDA to decide on SPN-830 apomorphine pump approval Feb. 1

The U.S. Food and Drug Administration (FDA) has set February 1, 2025, as its target date for deciding on the approval of SPN-830, an apomorphine infusion pump developed by Supernus Pharmaceuticals for managing “off” episodes in Parkinson’s disease. Supernus, which took over the rights to SPN-830 in 2020, has now filed four applications for approval. Parkinson's disease causes a gradual loss of dopamine-producing brain cells, leading to motor control issues. Standard treatments, like levodopa, temporarily boost dopamine levels, but their effects can wear off over time, causing symptoms to reappear during “off” episodes. Apomorphine, a dopamine mimic, is already approved in injection form (Apokyn) to reduce these off periods as needed. SPN-830 is a small, portable pump that delivers apomorphine continuously for over 10 hours, potentially keeping dopamine levels steady and reducing off episodes. Phase 3 trials in Europe (TOLEDO) and the U.S. (INFUS-ON) showed significant reduction in off time with SPN-830. Since its first application in 2020, the FDA has asked for additional data and revisions regarding SPN-830’s labeling, performance, risk analysis, and manufacturing. Supernus addressed these concerns, but the FDA recently requested further information on product quality and the infusion device's specifications.