The multi-center, double-blind, placebo controlled trial is a dose response study comparing 400mg and 600mg of Droxidopa to placebo in a total of 75 patients.
Following a two-week run-in period to establish baseline, patients in this three-arm study will receive a single oral dose of Droxidopa or placebo one hour prior to each dialysis treatment over a four-week period. The study will compare the change in mean blood pressure and symptomatic improvement during the final two weeks of treatment to baseline established prior to drug treatment.
Droxidopa is the company’s most advanced investigational product and is currently in development for the treatment of neurogenic orthostatic hypotension (NOH) as its lead indication. Chelsea plans to seek its first marketing approval for Droxidopa in NOH following the completion of its pivotal Phase III program in mid 2009.
Simon Pedder, president and CEO of Chelsea, said: “We are very pleased to have now completed enrollment in this Phase II study and look forward to the final results which should provide not only confirmation of the efficacy demonstrated in prior Japanese trials, but provide the specific data from which to determine the optimal dose for future development. We expect that treatment of patients will still be ongoing in this Phase II trial through December, and therefore data from all treated patients will be available during the first quarter of 2009.”