Teva Pharmaceutical Industries Ltd announced on August 12, 2015 that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization.
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.