Northera Confirmatory Trial Could Recruit Patients From Expanded Access Program
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA was unreceptive to Chelsea’s proposal to change endpoint in on-going 306B study to provide confirmatory efficacy data for droxidopa in neurogenic orthostatic hypotension.
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In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.
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