Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease
Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease
On Monday, Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson's disease (PD).
The FDA has issued a Complete Response Letter (CRL) in response to the company's New Drug Application (NDA) for SPN-830.
The CRL indicates that the review cycle for the application is complete but that the application still needs to be prepared for approval in its present form.
The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.
- The first area relates to product quality. The company recently submitted additional product quality data to the FDA, which it has not yet reviewed.
- The second relates to the master file for the infusion device, which is proprietary to the device manufacturer.
The company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830.
No clinical safety or efficacy issues were identified as a requirement for approval.
The FDA completed in February 2024 a preapproval inspection of the device manufacturer's facility.
In October 2022, the FDA granted a CRL for the SPN-830 marketing application when the agency said it required additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance, and risk analysis.
In October 2023, Supernus Pharmaceuticals resubmitted, and in November, the FDA acknowledged the resubmission of the application for SPN-830.
SUPN stock fell as much as 9% during the premarket session.
Price Action: SUPN shares are down 1.61% at $33.01 on the last check Monday.
Photo by Louis Reed via Unsplash
On Monday, Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson's disease (PD).
週一，Supernus Pharmicals Inc.（納斯達克股票代碼：SUPN）宣佈了對 SPN-830 的監管更新，這是一種正在研究中的阿撲嗎啡輸液設備，正在接受美國食品藥品管理局的審查，用於持續治療帕金森氏病（PD）的運動波動（“關閉” 發作）。
The FDA has issued a Complete Response Letter (CRL) in response to the company's New Drug Application (NDA) for SPN-830.
美國食品和藥物管理局已發佈了完整回覆信（CRL），以回應該公司的 SPN-830 新藥申請（NDA）。
The CRL indicates that the review cycle for the application is complete but that the application still needs to be prepared for approval in its present form.
CRL指出，申請的審查週期已經完成，但仍需要準備申請以目前的形式獲得批准。
The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.
CRL提到了兩個需要FDA進一步審查或向FDA提供額外信息的領域。
- The first area relates to product quality. The company recently submitted additional product quality data to the FDA, which it has not yet reviewed.
- The second relates to the master file for the infusion device, which is proprietary to the device manufacturer.
- 第一個領域與產品質量有關。該公司最近向美國食品和藥物管理局提交了其他產品質量數據，但尚未對其進行審查。
- 第二個問題與輸液設備的主文件有關，該文件是設備製造商的專有文件。
The company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830.
該公司計劃與設備製造商討論提供所需信息以及重新提交 SPN-830 保密協議所需的步驟。
No clinical safety or efficacy issues were identified as a requirement for approval.
沒有發現臨床安全性或療效問題需要批准。
The FDA completed in February 2024 a preapproval inspection of the device manufacturer's facility.
FDA 於 2024 年 2 月完成了對設備製造商設施的批准前檢查。
In October 2022, the FDA granted a CRL for the SPN-830 marketing application when the agency said it required additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance, and risk analysis.
2022年10月，美國食品藥品管理局批准了 SPN-830 上市申請的CRL，當時該機構表示需要與輸液設備和藥品相關的其他信息和分析，包括標籤、產品質量和製造、設備性能和風險分析。
In October 2023, Supernus Pharmaceuticals resubmitted, and in November, the FDA acknowledged the resubmission of the application for SPN-830.
2023 年 10 月，Supernus Pharmicals 重新提交，11 月，美國食品藥品管理局承認重新提交 SPN-830 申請。
SUPN stock fell as much as 9% during the premarket session.
SUPN股票在盤前交易時段下跌了9％。
Price Action: SUPN shares are down 1.61% at $33.01 on the last check Monday.
價格走勢：週一的最後一次支票中，SUPN股價下跌1.61％，至33.01美元。
Photo by Louis Reed via Unsplash
路易斯·裏德通過 Unsplash 拍攝的照片
譯文內容由第三人軟體翻譯。
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