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.

Chelsea Therapeutics International Ltd. believes that an ongoing study of Northera (droxidopa) in Parkinson’s disease patients could fulfill FDA’s request for more data on the norepinephrine prodrug’s efficacy and durability of effect in treating neurogenic orthostatic hypotension (NOH).

However, even if FDA determines that the ongoing trial, known as Study 306, could provide acceptable confirmatory evidence – a...

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