Feb 20 Chelsea Therapeutics International Ltd
said U.S. health regulators have informed the company
that it may reapply for the marketing approval of its
once-rejected hypotension drug Northera using data from its
Chelsea's shares more than doubled in value to $1.61 before
the bell on Wednesday, as the company said it plans to file for
approval for the drug in the second quarter of the year.
The U.S. Food and Drug Administration had rejected Northera
last March and asked Chelsea to conduct another clinical trial
to show the drug was effective over a longer period.
FDA's guidance was in response to a formal appeal by Chelsea
to the Director of the Office of New Drugs of the FDA, Chelsea
said in a statement.
"We now have a regulatory path forward, including the
potential for an approval of Northera later this year,"
Chelsea's interim Chief Executive Joseph Oliveto said.
In August, Chelsea changed the main goal of its earlier
study, codenamed 306B, and re-reported results in December
showing Northera significantly reduced dizziness in patients at
week one, but results beyond that period were not statistically
Chelsea said on Wednesday that the FDA guidance suggests
data from its completed 306B study strongly show a short-term
clinical benefit, but there was a possibility the regulator
would need a post-approval study to verify the drug's long-term
The company said it plans to start a new clinical trial in
the fourth quarter of the year to test for long-term benefits of
Northera is aimed at treating symptomatic neurogenic
orthostatic hypotension, or a chronic drop in blood pressure on
standing up that is most often associated with Parkinson's