Chelsea Therapeutics Intl Ltd fka CHIP

[surf1944]

7:06AM Chelsea Therapeutics reports interim results and plans to modify Study 306 to focus on reduction in falls associated with neurogenic orthostatic hypotension (CHTP) 6.18 : Co announces plans to modify Study 306, a Phase III study of NORTHERA (droxidopa) in symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease (PD) following a futility determination at the planned interim analysis of the study's primary endpoint and an unblinded review of multiple, secondary outcome measures showing dramatic reduction in falls and clear signs of therapeutic activity associated with Northera in the first 51 patients to complete Study 306. "We were therefore both surprised and encouraged to observe a 9 to 1 difference in the number of patients reporting falls as an adverse event in our relatively short Studies 301 and 302, and embraced the opportunity to prospectively assess the importance of this objective endpoint in Study 306. We believe the reduction of falls reported to date in Study 306 unequivocally supports the efficacy data generated to date by our Phase III trials and potentially affords us the opportunity to pursue future Northera label expansion to include the prevention of falls in neurogenic orthostatic hypotension associated with Parkinson's disease.