Chelsea Therapeutics International Ltd. (CHTP) has received a written response from the U.S. Food and Drug Administration or FDA to its modified proposal for utilizing data from ongoing Study 306B to support its application for marketing approval of Northera in the U.S. In its response, FDA advised Chelsea that, based on the theoretical potential for certain patients from Study 306B to have been unblinded in conjunction with the reporting of 306A data, the FDA cannot be confident that this information did not influence an amendment of the statistical analytic plan, and therefore believes, as presently planned, Study 306B is unlikely to provide sufficient confirmatory evidence to support a Northera Capsules New Drug Application or NDA.
The Advice Letter from the FDA stated "if an analysis of all subjects enrolled in study 306 after [Chelsea] amended the analytic plan demonstrated a statistically significant benefit on the primary endpoint, [FDA] might regard this as a positive trial." However, as this analytic approach seems to exclude at least 109 patients from Study 306B, the FDA further urges that Chelsea 'design and conduct an additional trial to show that droxidopa has a significant and persistent effect' on symptoms of neurogenic orthostatic hypotension.
Based on FDA's feedback, the company is now evaluating several scenarios that may provide the supportive data the FDA is seeking while minimizing any delays to the planned resubmission of its Northera NDA.
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