Chelsea initiates Phase II trial of hypotension drug

The double-blind, placebo controlled trial, being conducted at 15 sites in the US, 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 (12 dialysis sessions). 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 late 2008.

Simon Pedder, president and CEO of Chelsea, said: “We believe Droxidopa will prove to be a meaningful treatment option alleviating not only serious adverse events and complications associated with intradialytic hypotension, but also the disruption and repetition of dialysis sessions experienced by these patients.”