Chelsea Therapeutics International receives OK from FDA
Pharmaceutical company Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) reported this morning that the U.S. Food and Drug Administration has approved its Investigational New Drug application for Droxidopa.
The acceptance will permit Chelsea to begin Phase III clinical trials in neurogenic orthostatic hypotension (NOH) and move into the final stages for U.S. approval of Droxidopa as a treatment for NOH.
Droxidopa is an orally active synthetic precursor of norepinephrine currently approved and marketed in Japan for the treatment of orthostatic hypotension.
Symptomatic NOH is a neurogenic disorder that results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope. Chelsea estimates that nearly 300,000 patients suffer from chronic symptomatic NOH in the United States and EU combined.
Shares of Chelsea Therapeutics (CHTP) were halted in pre-market trading.
