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news.NeuroVive Pharmaceutical has completed the clinical phase of its study investigating tolerability and pharmacokinetics of the cremophor-free cyclosporine i.v. formula NeuroSTAT.
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The study was aimed at comparing the bioavailability and pharmacokinetics of cyclosporine after intravenous administration of NeuroSTAT, a Cremophor EL-free lipid emulsion, and Sandimmune Injection in healthy volunteers.
Eskil Elmr, CEO of Neuro Vive, said: “This study in 52 healthy subjects is a direct comparison of NeuroVive’s injectable cyclosporine product NeuroSTAT with Novartis’s product Sandimmune Injection. This is an important milestone in the development of the product for clinical use in patients with acute brain damage.”
“Further, if the final analysis of the study is successful it will open the opportunity to develop or outlicense the product NeuroSTAT for existing indications for intravenous cyclosporine A (such as immunosuppression). We expect to make NeuroSTAT available for clinical trials and sales on a named-patient basis.”
Greg Batcheller, chairman of Neuro Vive, said: “The completion of this trial represents an important step in the development of NeuroSTAT. It sets the stage for a next round of financing that will eventually take us into clinical trials in traumatic brain injury patients in Europe and the US.”
NeuroSTAT is an intravenous cyclosporine A lipid emulsion which is free from cremophor EL (castor oil) and alcohol.