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Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease

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SD-809 (deutetrabenazine) is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements. The FIRST-HD study showed a favorable safety and tolerability profile, including low rates of depression, somnolence, akathisia/restlessness and anxiety. The safety and tolerability experience observed in the ARC-HD study was consistent with the experience observed in the FIRST-HD study. The most commonly reported adverse events in ARC-HD patients were somnolence, fall, and nasopharyngitis.

SD-809 was granted Orphan Drug Designation for the treatment of HD by the FDA in November 2014 and became part of Teva’s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.

Teva plans to commercialize SD-809 in the U.S. by drawing from vast experience in facilitating therapy initiation and patient support in other disease areas.

 

The Official Coomunication by Teva on:

http://www.tevapharm.com/news/?itemid=%7BB77B4464-664B-4DC5-8373-F7D040CE2327%7D

 

 

 
 

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