Chelsea Therapeutics International of Charlotte will begin patient dosing in Phase III trials for Droxidopa in neurogenic orthostatic hypotension (NOH).
The plan for two pivotal trials evaluating a total of up to 236 patients followed a meeting on trial design with the FDA in August. The trails will occur during the fourth quarter of 2007. Both pivotal efficacy trials will have a primary endpoint of improvement in dizziness as measured by an orthostatic hypotension symptom assessment scale.
Earlier this week, the company said its rheumatoid arthritis drug CH-1504 has shown improvements over previous formulas according to a completed study.
Chelsea officials said tests reveal the disodium salt version of the drug is better absorbed in the human body and the company also reported a 1-milligram dose of the new formula is as effective as 15 milligrams of the original.