Mallinckrodt presents positive data on terlipressin in HRS-1

UK-incorporated specialty pharmaceutical company Mallinckrodt (NYSE: MNK) today announced positive results of a pooled analysis of terlipressin clinical trial data in patients with hepatorenal syndrome type 1 (HRS-1) at The Liver Meeting2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), held Nov. 9-13 in San Francisco.

The post-hoc pooled analysis of data from two previously completed Phase III, randomized, double-blind, placebo-controlled studies conducted in North America showed that treatment with terlipressin was associated with improved overall and transplant-free survival in HRS-1 patients with lower baseline mean arterial pressure (MAP). This effect was seen independent of HRS reversal, and may relate to a marked improvement in MAP and renal function in this patient group following administration of terlipressin.

Terlipressin is being investigated for the treatment of HRS-1, a rare, acute, rapidly progressing and life-threatening complication of liver cirrhosis that leads to renal failure. The safety and effectiveness of terlipressin have not yet been established by the US Food and Drug Administration.