BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

12:00 AM
 | 
Apr 25, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Northera droxidopa regulatory update

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...

Read the full 541 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >