Chelsea Therapeutics Falls on Flaws in Northera SubmissionMary Camille Izlar
Chelsea Therapeutics International Ltd. declined after saying U.S. regulators found formatting issues in its application for approval of its Northera drug for fainting.
Chelsea fell 8.1 percent to $2.82 at the close in New York. The Food and Drug Administration notified the company that there were deficiencies in the electronic datasets and statistical programs that will need to be fixed before the application is complete, Charlotte, North Carolina-based Chelsea said in a statement today.
The FDA said the incomplete submission isn’t related to study conduct, interpretability of study results, or validity of study conclusions, according to the statement. The company had resubmitted the drug earlier this month after the FDA requested additional data in March 2012.
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.
The FDA said a new deadline for its decision whether to approve the drug won’t be set until the flaws are fixed and a new submission is made. The company expects to present its response in August, according to the statement.