Tue Dec 4, 2012 6:17pm EST
(Reuters) – Chelsea Therapeutics Inc pronounced a initial hypotension drug met a categorical idea of a investigate by significantly shortening nausea in patients during week one, yet formula over that duration were not statistically significant.
The U.S. Food and Drug Administration declined to approve a drug, Northera, in March, and asked for information that valid it was effective over dual to 3 months.
The company’s shares, that have mislaid about two-thirds of a value so distant this year, fell 22 percent to $1.40 in extended trade after shutting during $1.79 on Tuesday on a Nasdaq.
Chelsea pronounced in Aug that it would cgange a categorical idea of a ongoing 306B study, yet a FDA had pronounced a investigate was doubtful to yield sufficient information for a selling focus and had suggested a association control an additional trial.
The drugmaker pronounced on Tuesday that rough information showed that over week one, dizziness/lightheadedness and station blood vigour primarily adored Northera-treated patients over placebo, nonetheless a formula were not statistically significant.
The drug, famous generically as droxidopa, is designed to provide symptomatic neurogenic orthostatic hypotension — a ongoing and mostly debilitating dump in blood vigour on station adult that is many mostly compared with Parkinson’s disease.
(Reporting by Vidya P L Nathan in Bangalore; Editing by Anthony Kurian)