Mallinckrodt (NYSE:MNK) announces the successful outcome of a Phase 3 clinical trial, CONFIRM, evaluating terlipressin in 300 adults with rapidly deteriorating kidney function called hepatorenal syndrome type 1 (HRS-1).
The study met the primary endpoint of verified HRS-1 reversal (renal function improvement, avoidance of dialysis and short-term survival) (p=0.012).
Detailed data will be submitted for presentation at a future medical conference.
The company expects to file a U.S. marketing application in Q1 2020.
Terlipressin is an analogue of vasopressin which is used to treat low blood pressure.
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