Vascular Depression, also called late onset depression, is often associated with the presence of cerebrovascular disease which is distinct from early onset depression: It can be a consequence of ischemic damage to cortical brain regions.

Vascular Depression is marked by greater cognitive and functional impairment and carries an increased risk for dementia and death. It is inadequately treated by conventional antidepressants where fewer than 50% of late onset depressed patients respond to these conventional treatments. One issue with using antidepressants alone is that the underlying vascular changes remain untreated and the disease remains progressive.

Fresh Approach to Combat Late Onset Depression

ARX-211 uses ARX-111 in combination with an SSRI. This is a fresh approach that targets the underlying vascular causes of late onset depression. Because both therapeutic entities are approved drugs, the combination can be developed under Section 505(b)(2) as a new indication using a novel formulation for a new combination product.

The Development Plan calls for Phase 2 trials in 2009 and market registration in 2011.