NeuroVive Pharmaceutical said that the results of the study demonstrated that NeuroSTAT is bioequivalent to Sandimmune injection and is safe and well tolerated.
The NeuroSTAT cyclosporine lipid emulsion is designed to be especially suitable in new indications for intravenous cyclosporine such as neuroprotection in traumatic brain injury and cardioprotection (in cardiac reperfusion injury) where, unlike immunosuppression, patients would not receive corticosteroid pre-medication.
In the trial, 52 healthy volunteers were administered single intravenous doses of each of the two cyclosporine formulations in a randomised single-blind cross-over washout design.
Rigorous statistical analysis of all 9 measured pharmacokinetic variables including maximum concentration (Cmax), half-life and area under the curve (AUC) established the bioequivalence of NeuroSTAT to Sandimmune injection, meeting the primary end-point.
Eskil Elmer, CEO of NeuroVive Pharma, said: “The successful study results are unreservedly positive. NeuroSTAT is bioequivalent to Sandimmune, yet free from Sandimmune’s risk of causing anaphylactic reactions.
“This is the foundation for the use of NeuroSTAT in clinical trials treating brain trauma and reperfusion injury during heart attack. It also opens commercial opportunities as a safer treatment for all existing indications where intravenous cyclosporine is used, such as organ and bone marrow transplantation.”