ROCKVILLE, Md., Feb. 24 (UPI) -- Otsuka Maryland Research Institute said Thursday it got fast-track status for tolvaptan to treat a serious kidney disorder.
The company said the Food and Drug Administration has fast tracked the treatment for a disease known as autosomal dominant polycystic kidney disease.
Fast-track status -- reserved for products that treat serious diseases and would fulfill an unmet medical need -- means the drug could be reviewed by the FDA within six months. The company can also use data gleaned at an earlier point in the study, known as surrogate endpoints.
The group said its drug is under study "as a preventive product for both a serious manifestation of the disease, increased renal size, and the secondary complications such as hypertension, proteinuria and renal pain."
In phase 2 studies tolvaptan has been associated with side effects that include increased thirst and urination, OMRI said.