TrioxBio announced that the Food and Drug Administration (FDA) has granted Fast Track designation for Raviten (MTR-107) for the reduction in hospitalizations or death in patients with end-stage renal disease (ESRD) undergoing hemodialysis and predisposed to developing intradialytic hypotension.
Intradialytic hypotension is a common complication of hemodialysis and can lead to increased morbidity and mortality among patients with end-stage renal disease. It may present in 1 of 3 patterns: acute (systolic BP drop <90 mmHg with clinical symptoms); recurrent (acute pattern prevalent in ≥30% dialysis sessions); or chronic, persistent (interdialytic systolic BP maintained at <90–100 mmHg). There is currently no approved treatment for this condition.
Raviten consists of S-ethylisothiouronium diethylphosphate solution for injection, which has been shown to inhibit inducible nitric oxide synthase (iNOS), endothelial NOS, and neuronal NOS. This controls the overproduction of nitric oxide and helps normalize low blood pressure in patients experiencing intradialytic hypotension. A 2003 study in Eastern Europe evaluated the the pharmacokinetic and pharmacodynamic effect of MTR-107 in ESRD patients and found that blood pressure was normalized for approximately 2 hours during the dialysis session without overshooting to excessive levels; no additional medical intervention was needed. In addition, the patients tolerated the study drug well and many of the hypotensive symptoms were resolved.
Phase 2 clinical trials are planned for Raviten in the 4th quarter of this year.
For more information visit TrioxBio.com.