Chelsea Therapeutics International Ltd. (CHTP:US) fell 25 percent in extended trading after releasing study results for Northera, a drug for fainting, and saying U.S. regulators told the company the clinical trial won’t help gain approval of the therapy.
Chelsea Therapeutics declined (CHTP:US) 44 cents to $1.35 in extended trading at 5:18 p.m. New York time after closing at $1.79. Shares of the Charlotte, North Carolina-based company have plunged 65 percent this year.
The drugmaker in March failed to win U.S. Food and Drug Administration approval of the therapy, which is used to treat drops in blood pressure in people with nervous system disorders. Regulators said a new clinical trial may be needed to assess the treatment’s effectiveness, the company announced in July.
Northera met its goals to reduce dizziness and lightheadedness in a trial of 147 patients and showed similar efficacy and safety as it did in an earlier study, Chelsea Therapeutics said today in a statement. The FDA previously advised the company that the study was unlikely to provide enough evidence to enable clearance of the medicine, Chelsea Therapeutics said.
The drug, also known as droxidopa, treats a condition known as neurogenic orthostatic hypotension. It afflicts about 180,000 patients in the U.S. leading to dizziness, lightheadedness, blurred vision and fainting, according to the company.
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