FDA To Review Supernus Pharma' NDA For SPN-830 Apomorphine Infusion Device

(RTTNews) - Supernus Pharmaceuticals Inc. (SUPN) said that the U.S. Food and Drug Administration has acknowledged the resubmission of the new drug application or NDA for its SPN-830, an apomorphine infusion device, for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease.

The resubmission is now considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.

In October 2022, The FDA declined to approve Supernus Pharmaceuticals Inc.'s SPN-830 proposed for the continuous treatment of motor fluctuations, i.e., OFF episodes, in Parkinson's disease.

The FDA had asked the company for additional information and analysis related to the infusion device and drug product across several areas, including labeling, product quality and manufacturing, device performance and risk analysis.

However, the regulatory agency had not requested additional efficacy and safety clinical studies.

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