Chelsea Therapeutics International Ltd. plunged the most in about three years after U.S. regulators said a new trial may be needed for Northera, a drug for dizziness and fainting that would be its first marketed product.
Chelsea fell 41 percent to 87 cents at the close in New York, for its biggest single-day drop since Sept. 24, 2009. The shares have declined 83 percent this year. The Food and Drug Administration called research on Northera inadequate, the Charlotte, North Carolina-based company said today in a statement.
The drugmaker in March failed to win FDA approval of the therapy, which is used to treat drops in blood pressure in people with nervous system disorders. Today, Chelsea said a follow-up letter from the agency recommended a new trial and found the existing study was unlikely to provide enough evidence to enable sales of the medicine.
“The FDA did acknowledge the ‘important need’ for a safe and effective therapy for these patients and indicated they were ‘anxious to work with us,’” Chief Executive Officer Simon Pedder said in the statement. The company said it was “evaluating several scenarios” to provide the data the regulators requested.
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, light-headedness, blurred vision and fainting, Keith Schmidt, sales and marketing vice president for Chelsea, told analysts on a Nov. 2 conference call.
An FDA reviewer in February recommended against Northera’s approval, linking the therapy to a life-threatening neurological disorder and saying it wasn’t proven to work long term. A panel of outside advisers voted Feb. 23 in favor of the drug because few treatments exist for the problem.