FDA accepts droxidopa IND for NOH
US biopharmaceutical firm Chelsea Therapeutics says that its developmental orthostatic hypotension treatment droxidopa has been accepted for review by the Food and Drug Administration. The drug, which is an orally-active norepinephrine precursor, is currently marketed in Japan and was granted Orphan Medicinal Product designation by European regulators earlier in the year (Marketletter August 20).
Chelsea said that it is seeking US approval to use droxidopa to treat neurogenic orthostatic hypotension, and plans to initiate large scale Phase III trials of the drug in that indication at sites in the USA and Europe over the next few months. The firm added that, if the study program is successful, it plans to submit a New Drug Application to the FDA early in 2009.
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