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Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data

 
• By Sue Sutter

Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.

Chelsea Therapeutics International Ltd. is adopting a two-pronged strategy to addressing FDA’s “complete response” letter for Northera (droxidopa) in neurogenic orthostatic hypotension. The company plans to expand an ongoing study and change its primary endpoint to provide confirmatory efficacy data, while also taking steps to bolster FDA’s confidence in the data from a completed pivotal trial.

Whether these moves will be enough to convince FDA of the durability of droxidopa’s effect and the reliability of the pivotal Study 301 data remains to be seen. The company...

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