www.fdanews.com/articles/177059-fda-fast-tracks-remedy-pharmaceuticals-cirara
FDA Fast Tracks Remedy Pharmaceuticals’ CIRARA
June 14, 2016
Remedy Pharmaceuticals has snagged FDA fast track designation for Cirara for the treatment of large hemispheric infarctions.
Cirara inhibits Sur1-Trpm4 channels, which can lead to edema, midline shift, increased intracranial pressure and brain herniation.
The company plans to initiate a Phase 3 study evaluating the candidate by the end of the year.