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Chelsea Therapeutics Drug Shouldn’t Be Approved, FDA Says

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Feb. 21 (Bloomberg) -- Chelsea Therapeutics International Ltd.’s drug to treat a condition that can cause dizziness in people with nervous system disorders may be unsafe and shouldn’t be approved, U.S. regulators said. The company’s shares fell.

The medicine, called Northera, lacks adequate data it works, Food and Drug Administration staff said today in a report. Agency advisers are set to meet Feb. 23 on whether the agency should approved the drug, chemically known as droxidopa. If so, it would be the first product marketed by the Charlotte, North Carolina-based company.

The FDA had previously expressed concern about the length of trials and reports of a life-threatening neurological disorder that may be linked to the drug, Chief Executive Officer Simon Pedder said in a Feb. 13 statement. Northera would treat a condition that causes blood pressure to drop within three minutes of standing up, Chelsea Therapeutics said.

“On the basis of the safety concerns compounded by absence of evidence of durability of effect,” the drug shouldn’t be approved at this time, the report said.

Chelsea Therapeutics fell 21 percent to $2.64 at 4 p.m. New York time. The company’s shares have fallen 22 percent in the past 12 months before today.

Neurogenic Orthostatic Hypotension

About 180,000 patients suffer from the blood pressure drop known as neurogenic orthostatic hypotension in the U.S., Keith Schmidt, Chelsea Therapeutics vice president of sales and marketing said on an earnings call Nov. 2. The FDA is scheduled to make a decision on approval by March 28.

Northera is available in Japan as part of a marketing agreement with Dainippon Sumitomo Pharma Co. and generates annual revenue of $50 million, Chelsea Therapeutics said on its website. The FDA is concerned that the drug has been associated with reports of a life-threatening neurological disorder known as neuroleptic malignant syndrome in patients in Japan, the company said. No incidents of the disorder have been reported in the company’s studies, Chelsea Therapeutics said in the Feb. 13 statement.

The company attempted to determine whether Northera works based on patients’ assessment of their symptoms and discovered researchers should have asked about different symptoms, including patients’ ability to make posture changes, Chelsea Therapeutics said in the statement.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net