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Company to Resubmit NDA in Late Second Quarter 2013
Short-term Clinical Benefit Adequate to Support Approval
Company to Host Conference Call Today at 9:00 AM ET
CHARLOTTE, N.C., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that it has received written guidance from the Director of the Office of New Drugs ("the Director") at the U.S. Food and Drug Administration (FDA) stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera™ (droxidopa) New Drug Application (NDA) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The guidance is in response to a formal appeal by Chelsea to the Director, and follows a meeting with the Director and top staff from the Office of Drug Evaluation I and Division of Cardiovascular and Renal Products (DCRP) at the FDA's Center for Drug Evaluation and Research.
The guidance suggests that "data strongly demonstrating a short-term clinical benefit (e.g., improvement in symptoms or ability to function) 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 this guidance, Chelsea plans to file a resubmission of the Northera NDA with the DCRP in the late second quarter of 2013. If accepted by the Division, the Company's application will be subject to a 6-month review period.
"We appreciate and are encouraged by FDA's willingness to consider data from Study 306B in evaluating Northera for the treatment of NOH, and look forward to submitting the totality of our clinical experience to date to the Agency for review," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "We now have a regulatory path forward, including the potential for an approval of Northera later this year."