September 11, 2009 (FinancialWire) — Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) has successfully reached its target enrollment of 118 randomized patients for Study 301, the second of two pivotal Phase III clinical trials in Chelsea’s registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension .

“With top-line data from Study 302 expected within weeks, reaching our target enrollment in Study 301 marks a significant turning point in our Droxidopa development program as we conclude our clinical efficacy evaluations and move ahead with our regulatory submission and commercialization efforts,” commented Dr. Simon Pedder, Chelsea’s president and CEO. “Top-line data from Study 301 is expected late next quarter and we anticipate initiating a rolling NDA submission in the same quarter.”

The Droxidopa Phase III registration program in NOH includes two highly similar, double-blind, placebo-controlled studies: Study 301 and Study 302. Both studies compare Droxidopa to placebo for the treatment of symptomatic NOH and are designed to demonstrate a mean improvement over placebo of 1.6 units on the Orthostatic Hypotension Symptom Assessment scale. The OHSA scale is a validated scale designed to rate symptoms occurring specifically because of low blood pressure and uses an 11-point scale (zero to 10), with more severe symptoms scoring higher. To date, both studies have demonstrated a greater than 4 unit improvement on the OHSA scale during their respective open-label dose titration phases. Given the relatively short duration of the study, top-line data from Study 302 is expected late in the third quarter of 2009.

Study 301was reviewed by the U.S. Food and Drug Administration and awarded a Special Protocol Assessment in February 2008. 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. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process.

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