Teva to file for approval of SD-809 following more positive top-line Ph III results in tardive dyskinesia

Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) has announced that SD-809 (deutetrabenazine) showed statistically-significant results in the second Phase III registration trial studying the potential of SD-809 for the treatment of tardive dyskinesia (TD). Teva stock rose 1.49% to $51.23 during the last trading session.

These new results for the AIM-TD trial follow positive results from the ARM-TD trial announced in June 2015. Both ARM-TD and AIM-TD were 12 week treatment studies. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for SD-809 for the treatment of TD in November 2015. Teva expects to make a regulatory submission to the FDA by the end of 2016.

Earlier this year Teva received a Complete Response Letter from the FDA asking it provide more information on its New Drug Application for deutetrabenazine, the first deuterated product to be reviewed by the agency, for the treatment of chorea associated Huntington disease (HD). SD-809 became part of Teva’s central nervous system product portfolio with the $3.2 billion acquisition of Auspex Pharmaceuticals, completed in May 2015.