By Stephen Nakrosis
Supernus Pharmaceuticals resubmitted a new drug application to the Food and Drug Administration for its apomorphine infusion device to treat patients with Parkinson’s disease.
The SPN-830 apomorphine infusion device is designed for the continuous treatment of motor fluctuations in Parkinson’s disease.
In October 2022, Supernus said it received a complete response letter from the FDA indicating the company’s NDA wouldn’t be approved in its then-current form. At the time, Supernus said the FDA was seeking additional information and analysis, but didn’t request additional efficacy or clinical studies.
The company also said “the FDA mentioned at the time that approval of the NDA required inspections that could not be completed in a timely manner due to Covid-19 travel restrictions.”
Supernus said it believes it addressed the FDA’s questions related to the complete response letter and will continue to work with the agency as it reviews the SPN-830 NDA.
Write to Stephen Nakrosis at [email protected]
This news item came from: https://www.marketwatch.com/story/supernus-resubmits-nda-to-fda-for-apomorphine-infusion-device-to-treat-parkinson-s-9114a872
