Droxidopa is an oral precursor of norepinephrine (NE). Droxidopa crosses the blood-brain barrier and increases noradrenergic transmission in the central and peripheral nervous systems. It is converted centrally and
peripherally to NE via dopa-decarboxylase to increase NE, subject to homeostatic control.
Chelsea acquired the global development and commercialization rights to droxidopa (L-DOPS) from Dainippon Sumitomo Pharma
Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan, and conducted multiple clinical trials investigating the safety and efficacy of the drug.
In September of 2011, Chelsea submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market droxidopa in the United States for the treatment of symptomatic neurogenic orthostatic hypotension (Neurogenic OH or NOH). The clinical portion of the NDA filing comprises pooled safety and efficacy data from two finalized Phase III studies in Neurogenic OH, studies 301 and 302, two long-term open-label extension studies, a comprehensive QTc study, and a 24-hour ambulatory blood pressure monitoring safety study. Droxidopa was previously granted Orphan Drug status and received Fast Track status from the FDA. An Orphan Drug designation gives preferential patent protection to drugs that are intended to treat disorders affecting fewer than 200,000 people in the US. Fast Track status is intended to expedite the review process of drugs that address serious health conditions for which there is an unmet medical need.
The NDA was accepted for review by the FDA in November of 2011. The FDA also granted Chelsea's request for Priority Review.
Droxidopa is an investigational new drug not currently marketed in North America and the European Community. No claims on the safety and efficacy of droxidopa for the treatment of neurogenic orthostatic hypotension are being made, implied, or intended by the resources contained here within.