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CHTP Chelsea therapeutics change of primary endpoints


7:33AM Chelsea Therapeutics announces several updates related to its Phase III registration program in neurogenic orthostatic hypotension (CHTP) 2.72 : Co announces several updates related to its Phase III registration program in neurogenic orthostatic hypotension, including the selection and preliminary approval by the FDA of Northera as the U.S. brand name for Droxidopa in this indication. As previously announced, Chelsea had a successful meeting with the FDA last quarter during which the company reviewed results from Study 302, its first Phase III trial of Northera in NOH, and requested a change in primary endpoint for its ongoing Phase III trial, Study 301. The FDA granted this request and further supported Chelsea's decision to increase enrollment in Study 301 from 118 patients to 150 patients. The FDA subsequently confirmed that the Special Protocol Assessment originally awarded to Study 301 in 2008 remained in effect following the protocol amendments approved by the FDA in December. An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. Chelsea plans to complete the added enrollment in Study 301 during the second quarter and report top-line data from the study in the third quarter 2010. In addition to implementing changes to Study 301, Chelsea finalized its plans for Study 306, a confirmatory study supporting the efficacy of Northera in treating symptomatic NOH. Study 306 will be a multinational, randomized, placebo-controlled, induction-design Phase III trial evaluating up to 84 patients with symptomatic NOH associated with Parkinson's disease. Enrollment, which is scheduled to begin during the second quarter 2010, is expected to be complete by year-end, providing for top-line data in the second quarter of 2011.