ARTICLE | Clinical News

Northera droxidopa regulatory update

April 25, 2011 7:00 AM UTC

Based on additional feedback from FDA, Chelsea still plans to submit an NDA next quarter for Northera droxidopa to treat neurogenic orthostatic hypotension (NOH) based on efficacy data from two completed Phase III studies, Study 301 and Study 302. Chelsea reiterated that it will not seek a label claim that Northera reduces falls due to NOH associated with Parkinson's disease (PD), a claim Chelsea said was suggested by anecdotal evidence in the adverse events recorded in Study 302. The company subsequently decided to assess the falls benefit as a secondary endpoint in the ongoing Phase III Study 306, which the company said will serve as the basis for a future sNDA to expand the label to include the falls claim. ...