Chelsea Therapeutics International Ltd. (CHTP) announced it has received written guidance from the Director of the Office of New Drugs at the U.S. FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera New Drug Application for the treatment of symptomatic neurogenic orthostatic hypotension.
The guidance suggests that data strongly demonstrating a short-term clinical benefit of droxidopa in patients with NOH would be adequate for approval, with a possible requirement to verify durable clinical benefit post-approval. It further notes that any decision regarding the outcome of an FDA review, to be performed by the DCRP will be based on the strength of Study 306B and its ability to provide substantial evidence of effectiveness to support approval.
Based on the guidance, Chelsea plans to file a resubmission of the Northera NDA with the DCRP in the late second quarter of 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013.
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