Chelsea Therapeutics Announces Interim Results And Plans To Modify Study 306 To Focus On Reduction In Falls Associated With Neurogenic Orthostatic Hypotension

• Independent Data Monitoring Committee Concludes Continuation of Study Using Subjective OHQ Composite Endpoint Futile While Unblinded Analysis Reveals Robust Efficacy Reflected in Objective Falls Endpoint
• Parkinson's Disease Patients Treated With Northera Demonstrate 60% Decrease in Falls
• Chelsea Plans to File Primary Northera NDA for Symptomatic Neurogenic Orthostatic Hypotension Based on Efficacy Data From Previously Completed Studies 301 and 302 and Seek sNDA for Potential Falls Claim Based on Results of Study 306
• Management to Host Conference Call to Discuss Results at 8:30 AM ET

CHARLOTTE, N.C., Feb. 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) 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 .

"While fully characterizing the symptomatic benefit of Northera in neurogenic orthostatic hypotension has historically been difficult given the inherent variability and limitations of subjective patient reported outcomes, our primary goal has always been to demonstrate the potential improvements to patients' daily lives," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "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."