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Auspex’s SD-809 gets FDA orphan drug status to treat Huntington’s disease

US-based Auspex Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational compound SD-809 to treat Huntington's disease, a neurodegenerative movement disorder that impacts cognition, behaviour and movements.

Currently, the company is evaluating the efficacy and safety of SD-809 to treat chorea associated with this disorder in a Phase III registration clinical trial and is scheduled to report topline data from this trial in December 2014.

Auspex president and CEO Pratik Shah said: "The orphan drug designation of SD-809 marks a major regulatory milestone for Auspex and a significant step forward in our goal to bring this novel treatment approach to patients as quickly as possible.

"Huntington’s disease is a rare and devastating genetic disorder with very limited treatment options. The orphan drug designation recognizes the significant need that exists among individuals living with this disease."

The company uses its proprietary technology to create patent-protected, new chemical entities from known, clinically proven pharmacologics.

Additionally, the company is investing in the broad potential of SD-809 to treat other movement disorders, including tardive dyskinesia and tics associated with Tourette syndrome.