Northera droxidopa regulatory update

Chelsea said it plans to modify the ongoing Phase III Study 306B trial of Northera droxidopa based on a meeting with FDA about a complete response letter for the neurogenic orthostatic hypotension (NOH) product. The company, which received the letter in March, hopes to resubmit an NDA in 1Q13.

After reaching "apparent consensus" with the agency, Chelsea will change the trial's primary endpoint to measure orthostatic hypotension symptom assessment scale (OHSA) item 1 score (dizziness or light-headedness) at 2 weeks post-titration; the current endpoint is measuring a reduction in falls. Chelsea also plans to increase enrollment to 200 from 160. The trial already enrolled 161 patients. ...