Chelsea Therapeutics International has reported positive preliminary results from a Phase III trial evaluating Northera (droxidopa) in Parkinson's disease patients with symptomatic neurogenic orthostatic hypotension (NOH).
Northera demonstrated statistically significant improvement over placebo in reduction of dizziness and lightheadedness at week one (p=0.018), the primary endpoint, and standing blood pressure at week one (p=0.032), a key secondary endpoint in study 306B.
University of South Florida Parkinson's Disease Movement Disorders Center director, professor of neurology, molecular pharmacology and physiology and study principal investigator Dr Robert Hauser said the current data is consistent with prior studies.
"They demonstrate an improvement in dizziness and lightheadedness and suggest a reduction in falls for patients taking Northera. In addition, Northera was well tolerated, with a relatively low incidence of supine hypertension," Hauser said.
Treatment with Northera resulted in fewer patient falls and fall-related injuries, although these results were not statistically significant.
Preliminary safety data showed that Northera was well-tolerated at all tested dosages, and demonsted consistent safety results with those from previous studies.
Chelsea interim CEO Joseph Oliveto said the 306B results are consistent with the safety and efficacy of Northera observed in the previous randomiszed, controlled trials.
"Furthermore, we now have studied over 650 NOH patients, constituting a large safety and efficacy database in this orphan indication," Oliveto said.
The FDA had earlier advised Chelsea that study 306B is unlikely to provide sufficient confirmatory evidence to support a new drug application for Northera.