March 28 Chelsea Therapeutics International Ltd
said U.S. health regulators rejected its hypotension
capsule Northera and sought an additional trial to support the
efficacy of the drug.
The U.S. Food and Drug Administration recommended that the
trial be designed to show the drug was effective over two to
The FDA also made a preliminary recommendation to include a
black-box warning -- signifying serious or life-threatening
risks -- related to supine hypertension.
Chelsea said it would request a meeting with the FDA to
address the agency's recommendations. In February, FDA staff had
advised against approval of Northera, citing safety concerns.
The drug, known generically as droxidopa, is designed for
symptomatic neurogenic orthostatic hypotension -- a chronic and
often debilitating drop in blood pressure on standing up that is
most often associated with Parkinson's disease.
Northera has an orphan status, which is granted by the
regulator to drugs that treat a rare condition affecting less
than 200,000 Americans and guarantees a marketing exclusivity of
seven years in the country.
The drug, in use in Japan since 1989, has shown some
post-marketing safety issues and is being tested in an ongoing
trial. Results from this study are expected in the third quarter
Shares of the Charlotte, North Carolina-based
biopharmaceutical company closed down 3.4 percent at $3.67 on
Wednesday on the Nasdaq.