Date: 2014-04-28
Type of information:
phase: 2
Announcement: publication of a Phase II study in Liver Transplantation
Company: Veloxis Pharmaceuticals (Denmark)
Product: Envarsus® (LCP-Tacro™)
Action
mechanism: Envarsus® (LCP-Tacro™) is an investigational drug that is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products. This extended release formulation of tacrolimus has been designed for once-daily dosing, flatter pharmacokinetics and greater bioavailability compared to twice-daily tacrolimus or Prograf®
Disease: prevention of graft rejection in kidney transplantation
Therapeutic area: Transplantation
Country:
Trial details:
Latest
news: * On April 28, 2014, Veloxis Pharmaceuticals has announced the publication of a Phase II study demonstrating conversion from twice-daily tacrolimus to once-daily Envarsus® in stable liver transplant patients in Liver Transplantation. The study was published online in Liver Transplantation. Adult liver transplant patients stable on twice-daily tacrolimus were converted to and maintained on Envarsus® for up to six months to evaluate pharmacokinetics (PK) and a 52-week safety evaluation. 57 patients completed Envarsus® dosing in the core study (days 8-21) and 43 patients completed the extension phase. Similar to what was observed in kidney transplant clinical trials, the mean Envarsus® dose was approximately 30% less than that of the twice-daily tacrolimus dose. Envarsus® demonstrated significantly lower peak blood levels and less peak-to-trough fluctuation. The pharmacokinetics of Envarsus® after 6 months of therapy are comparable to those after 14 days of therapy. Envarsus® was well tolerated with no new safety concerns. The article can be found at: http://onlinelibrary.wiley.com/doi/10.1002/lt.23844/abstract.
