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Chelsea’s FDA Appeal Succeeds; Northera Can Skip Durability Of Effect Study

This article was originally published in The Pink Sheet Daily

Executive Summary

Bogged down since last March by a “complete response” letter, Chelsea has been informed by FDA that a recently completed Phase III trial will be sufficient to back a re-filed NDA for droxidopa in NOH related to Parkinson’s disease.

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

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.

Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says

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.

Northera Review Shows Regulatory Challenges In Difficult Therapeutic Space

Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.

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