Results of phase III trial of Envarsus XR (tacrolimus) in transplant rejection published in Clinical Transplantation- Veloxis Pharma

Veloxis Pharmaceuticals is announcing the publication of the Phase IIIb Switching STudy of Kidney TRansplant PAtients to LCP-TacrO (STRATO) in the journal Clinical Transplantation. The STRATO study was an open-label, multicenter study demonstrating that kidney transplant patients treated with once-daily Envarsus XR (tacrolimus) experienced a reduction in hand tremors following conversion from twice-daily tacrolimus, while maintaining comparable tacrolimus exposure. The results of this study have been presented previously at the 13th American Transplant Congress.

Tremor is a common side effect of tacrolimus correlated with peak-dose drug concentration and is associated with a decrease in the quality of life (QOL). Switch from twice-daily tacrolimus to Envarsus XR resulted in improvement in FTM total score, tremor amplitude as measured by Tremorometer and quality of life. Both the patient- and physician-reported global assessments demonstrated significant overall improvement following the switch to Envarsus XR.