Chelsea Therapeutics Still Alive: 306b Trial Supports Northera Efficacy And Safety

Chelsea Therapeutics (CHTP) released preliminary results for its Phase III clinical study, called 306b, which evaluated the efficacy and safety of Northera, the company's drug candidate for symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease. NOH is associated with a sharp drop in blood pressure -- patients often have trouble standing for long periods of time and will generally fall more often. Falling is a big problem with Parkinson's disease patients and can lead to severe complications and even death. Therefore, Northera could be an important treatment in this disease. Data from the 306b trial were favorable overall, with the study meeting its primary endpoint. However, the lack of a long-lasting effect -- which the FDA stated previously that it would like to see -- as well as no statistical significance on Northera's ability to reduce the number of falls are causing investors to sell the stock Wednesday.

Northera works; will the FDA take another look? The company has now generated clinical results for Northera in roughly 650 NOH patients, and based on the 306b study and the prior 301 and 302 trials, Northera has demonstrated a clear efficacy signal and good safety. So much so that an FDA advisory panel recommended the drug for approval in February. However, the FDA ended up going against the panel and rejecting Northera based solely on the 301 and 302 trials, as efficacy was only demonstrated for a couple of days, and the data on patient "falls" were not well-characterized. Because FDA has stated previously that the 306b study would not be adequate for approval, the company remains in search of a path forward.


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