STRATO study of LCP-Tacro (Veloxis Pharmaceuticals) shows benefits for Kidney Transplant patients

Data from the STRATO study demonstrates the potential for LCP-Tacro (tacrolimus once daily), from Veloxis Pharmaceuticals, to improve tacrolimus-induced tremors in stable Kidney Transplant patients. In this open-label trial, 44 kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of hand tremor were switched to once-daily LCP-Tacro. Tremor was evaluated using the FTM scale and by an objective measurement of tremor frequency and amplitude by Tremorometer.

Both the patient- and physician-reported global assessments demonstrated significant overall improvements following the switch to LCP-Tacro (Total improvement=15% p<0.001). the functional impact assessment showed a 35 improvement with a 5 improvement in tremor severity and a 9 improvement in motor task performance. data was presented at the 13th american transplant congress. in april 2013 veloxis pharmaceuticals submitted a maa to the ema seeking approval to market lcp-tacro for the prevention of organ rejection in kidney transplant patients in the eu.>