Chelsea Therapeutics International, Ltd. (CHTP: Quote) announced results from an integrated dataset of two phase 3 studies, Study 301 and Study 302, which showed that patients treated with Northera (droxidopa) experienced improvements in their symptoms of Neurogenic Orthostatic Hypotension (also known as NOH or Neurogenic OH) as measured by the Orthostatic Hypotension Questionnaire (OHQ) composite score (p=0.001) and a number of individual symptoms, including dizziness (p=0.004).
The results, which include data from over 250 patients with symptomatic Neurogenic OH and diagnoses of Parkinson's disease, multiple system atrophy (MSA), pure autonomic failure (PAF), dopamine beta hydroxylase deficiency or nondiabetic autonomic neuropathy, were presented by Christopher Mathias, MD at the 16th International Congress of Parkinson's Disease and Movement Disorders in Dublin, Ireland.
Gregor Wenning, MD presented data showing that patients with pure autonomic failure and MSA showed statistically significant improvement in the OHQ composite score following droxidopa treatment versus placebo (p=0.022 and p=0.018, respectively). The data also showed that age is an important contributor to improvements seen in patients with Parkinson's disease. Parkinson's disease patients younger than 65 treated with droxidopa showed greater improvements versus placebo than those over 75 (1.63 units vs. -0.04 units).
Phillip Low, MD presented data from a post-hoc analysis which showed that 94 patients taking midodrine at screening presented with more severe condition at baseline as measured by OHQ composite score (6.7 vs. 5.8), yet after treatment with droxidopa, all patients had improvement in OHQ regardless of previous midodrine use.
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by RTT Staff Writer
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