PharmaIN and LAT Pharma have announced the issuance of FDA orphan-drug designation for terlipressin as treatment of ascites due to all etiologies apart from cancer.
The companies are developing long-acting PHT101(PGC-C12E-Terlipressin)for once-daily subcutaneous injection dosing in outpatient populations.
PharmaIN president Elijah Bolotin said,"We are excited about the medical potential of PHT101,which synergistically incorporates two of our proprietary technologies designed to enable safer and more effective drug therapy:PGC-Hydrophobic Core nanocarrier-based delivery and unique fatylation that leads to a pro-drug."
Terlipressin down-regulates the extreme salt and water retention that leads to ascitic fluid buildup by increasing mean arterial pressure(MAP)in cirrhotic patients with splanchnic vasodilation and reducing portal vein pressure.
LAT Pharma chief scientific officer John Thottathil said,"PHT101 would bring a novel,mechanistic approach to ascites therapy as opposed to the current standard of care involving symptom relief."