Phase III data shows efficacy and safety of SD 809 (deutetrabenazine) in Huntington Disease- Teva Pharmaceutical

Teva Pharmaceutical has announced new data from the Phase III placebo-controlled and randomized First Time Use of SD 809 (deutetrabenazine) in Huntington Disease (First-HD) study evaluating the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington disease (HD). A total of 90 patients were enrolled in the First-HD study for evaluation over 13 weeks. Patients underwent dose titration over the initial 8 weeks of treatment followed by 4 weeks of maintenance therapy. The overall treatment period was 12 weeks, followed by a 1-week washout period.

The Phase III First-HD study data showed that deutetrabenazine improved chorea. In the Phase III First-HD study, data showed deutetrabenazine significantly improved swallowing as measured by the Swallowing Disturbance Questionnaire (SDQ). Additional data set shows significant improvement in total motor score (TMS) with contributions from improved dystonia. The most common adverse reactions reported (greater than 5% and greater than placebo) were: somnolence, dry mouth, diarrhea, insomnia, and fatigue.The data will be featured at the 68th American Academy of Neurology (AAN) meeting.

Comment: 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.