Chelsea Therapeutics International of Charlotte began a Phase II trial of Droxidopa, a drug used to treat patients with intradialytic hypotension.
"Given its demonstrated success in treating the symptoms associated with hypotension in hemodialysis patients in Japan, we are pleased to have begun our Phase II dose response study here in the U.S.," said Dr. Simon Pedder, the company's president and chief executive officer.
Droxidopa is the company's most advanced investigational product and is in development for the treatment of neurogenic orthostatic hypotension as its lead indication. Chelsea will seek its first marketing approval for Droxidopa after completing its pivotal Phase III program in late 2008. Chelsea currently has U.S. sites open and is actively screening patients.