FDA Accepts Chelsea Therapeutics’ IND for Droxidopa

The FDA has accepted Chelsea Therapeutics’ investigational new drug (IND) application for Droxidopa, an orally active synthetic precursor of norepinephrine.

The acceptance allows Chelsea to begin two Phase III clinical trials in neurogenic orthostatic hypotension with up to 236 patients. The primary endpoint for each trial will be a statistically significant improvement in symptomatic benefit between active and placebo, as defined by the Orthostatic Hypotension Symptom Assessment scale.

Chelsea said it expects to complete both studies by the end of 2008, allowing for a new drug application to be filed with the FDA early in 2009.