Chelsea Thera gets disappointing news from FDA on Northera

US biotech firm Chelsea Therapeutics International (Nasdaq: CHTP) shares tumbled in pre-market trading yesterday, after it received a written response from the Food and Drug Administration to the company’s modified proposal for utilizing data from ongoing Study 306B to support its application for marketing approval of Northera (droxidopa) in the USA as a treatment for symptomatic orthostatic hypotension (SOH). The stock, already down significantly this year, fell a further 51% to $0.71.

In its response, the 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.

Agency suggests additional trial