CHARLOTTE, N.C. – Chelsea Therapeutics (Nasdaq: CHTP) plans to speed up its New Drug Application process for a proposed neurogenic disorder drug following a meeting with the Food and Drug Administration.
The company’s Northera targets orthostatic hypotension, a chronic disorder, associated with Parkinson’s disease. Chelsea is hoping to win FDA approval in 2011. Northera has already received fast-track as well as orphan drug status from the FDA, which grants marketing and other advantages.
The FDA agreed with Chelsea’s plans after review of two Phase III study results but did request some additional information, the company said.
“The successful outcome of our pre-NDA meeting with the FDA reflects the strength of the data already generated by our pivotal program and marks a significant step forward for Chelsea,” said Chelsa Chief Executive Officer Simon Pedder in a statement.
“We believe that the Phase III trials we have already completed, combined with the extensive
Japanese and European data available to us, clearly demonstrate Northera’s meaningful clinical benefit to patients whose day to day lives are severely impacted by the signs and symptoms of neurogenic
orthostatic hypotension. Furthermore, based on feedback received during the meeting and subsequent correspondence, we believe the safety profile of Northera is unlikely to result in a black box warning for
supine hypertension in its label.”
The only other approved treatment for the condition carries a warning for side effects, Chelsea noted.
The disorder causes lightheadedness, dizziness, blurred vision and fainting.
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