Teva Pharmaceutical  announced that the U.S. FDA has granted Breakthrough Therapy Designation status to SD-809 (deutetrabenazine) for the treatment of patients with moderate to severe tardive dyskinesia, a hyperkinetic movement disorder affecting about 500,000 people in the United States.   Tardive dyskinesia, for which there are no approved therapies in the United States, has been described as a condition characterized by repetitive and uncontrollable movements of the tongue, lips, face, and extremities .    SD-809 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’s disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements.

 

Source:

http://www.tevapharm.com/news/teva_announces_breakthrough_therapy_designation_for_sd_809_granted_by_fda_for_the_treatment_of_tardive_dyskinesia_11_15.aspx