Supernus Reports the US FDA’s Acceptance to Review SPN-830’s Resubmitted NDA for the Treatment of Off Episodes in Parkinson’s Disease
Shots:
- The US FDA has accepted to review the resubmitted NDA of SPN-830, apomorphine infusion device, for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD) with the decision expected in Apr 2024
- The NDA was resubmitted following the initial refusal to file (RTF) due to inadequate data, which had occurred after the original NDA submission in Sep 2020
- The original NDA was based on data from the P-III (TOLEDO) trial that demonstrated a significant reduction in OFF time, with an improvement of 1.89hrs. per day vs PBO. These improvements were observed within 1wk. of initiating the therapy
Ref: Globenewswire | Image: Supernus
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
