Orphan Drug Designation Granted for Terlipressin Formulation for Ascites
PharmaIN and LAT Pharma announced that the FDA has granted their request for orphan drug designation for terlipressin for the treatment of ascites due to all etiologies except for cancer. PHT101 (or PGC-C12E-Terlipressin) incorporates novel drug delivery technologies that may enable once-daily administration via subcutaneous injection dosing in chronic outpatient populations. Terlipressin reduces portal vein pressure and increases mean arterial pressure (MAP) in cirrhotic patients with splanchnic vasodilation. Increasing MAP in ascites patients could potentially down regulate the excessive salt and water retention that leads to ascitic fluid buildup.
PHT101 is in preclinical testing.