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Chelsea Therapeutics OK’d To Change Droxidopa Pivotal Study 301

December 16, 2009 (FinancialWire) — Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) said the FDA has agreed to allow the company to modify the primary endpoint and enroll an additional 24 patients in Study 301, a pivotal Phase III study of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension .

The primary endpoint of the trial will now be the relative mean change in the Orthostatic Hypotension Questionnaire composite score between Droxidopa and placebo. The OHQ composite score is a single endpoint that reflects the average of the composite orthostatic hypotension symptom assessment score and the composite orthostatic hypotension daily activities scale (OHDAS) score. The FDA agreed that the revised primary endpoint reflects a more comprehensive global assessment of the clinical benefit of Droxidopa for the treatment of symptomatic NOH in primary autonomic failure, a heterogeneous population consisting of patients suffering from Parkinson’s Disease, multiple system atrophy and pure autonomic failure and would therefore be suitable for supporting a symptomatic claim.

To further de-risk the study and maximize the potential significance of the outcome, Chelsea has decided to increase the power of the study to greater than 80% by randomizing an additional 24 patients into Study 301. The company plans to reopen enrollment at select North American centers. Based on discussions with study investigators, historical rates of recruitment and the total patient requirement, Chelsea anticipates that Study 301 will complete enrollment by the end of the second quarter 2010, allowing for top-line study data in the third quarter of 2010.

The FDA confirmed that while Study 302, which failed to achieve statistical significance using only item 1 of the OHSA as a primary endpoint, and so could not be used as a pivotal study, it did provide valuable information about the benefits of Droxidopa. Both the safety and efficacy data from this study will be considered to be a supportive part of future regulatory filings. Further, the agency indicated that the number of patients already enrolled in Chelsea’s pivotal program would be sufficient to support an NDA in this indication.

The FDA has, however, also recommended that Chelsea submit a confirmatory study to support an NDA filing. The FDA indicated that such a study could be contained to a small, highly enriched, homogeneous patient population. The FDA also suggested Chelsea utilize an innovative design with the option to include multiple crossovers, wherein each patient serves as his or her own control, minimizing individual patient variability.

Based on these recommendations, Chelsea said it will initiate a new clinical trial, Study 306, early in 2010. While final study protocols are still being finalized, the company anticipates that a prospective study would seek to evaluate the efficacy of Droxidopa in approximately 35-45 PD patients with symptomatic NOH using the OHQ score as the primary endpoint. The company anticipates that a trial of this scope could be completed by the end of 2010, allowing for an NDA filing in early 2011.

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