#SUPN received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its NDA for SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations (“on-off” episodes) in Parkinson’s disease (PD). "In its review of the NDA, which was submitted in September 2020, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. In the letter, the FDA requested certain documents and reports to be submitted in support of the application.
The Company plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN-830.
“On SPN-812, we look forward to collaborating with the FDA to clarify and resolve the facility matter and put SPN-812 back on track to help the millions of children and adolescents in the U.S. with ADHD,” said Jack Khattar, President and CEO of Supernus. “Regarding SPN-830, we remain confident in the data package for SPN-830 and its promise as an important treatment option for PD patients who experience motor fluctuations associated with on-off episodes. We are fully committed to working with the FDA to address its letter and successfully refile our SPN-830 NDA.” The Company plans to provide updates on the NDA status and expected launch timing for both SPN-812 and SPN-830 once it has had further discussions with the FDA and has agreed on the path forward for each program" (see press release HERE).
See our SUPN SPN-830 AmpCard here.