Top-line results from a phase 3 trial of terlipressin (Mallinckrodt) found that the investigational treatment successfully reversed hepatorenal syndrome type 1 (HRS-1), the primary end point of the study.
Terlipressin is a vasopressin analogue selective for V1 receptors. In the CONFIRM trial, adult patients with HRS-1 (N=300) were randomized to receive either terlipressin intravenously as a bolus injection over 2 minutes at a dose of 1mg every 6 hours or placebo.
Results showed that compared with placebo, a greater percentage of patients treated with terlipressin had verified HRS-1 reversal (defined by 3 components: renal function improvement, avoidance of dialysis and short-term survival) within 15 days (P =.012); additional findings from the study will be presented at an upcoming medical meeting, according to the Company.
“We anticipate the complete results will continue to help inform the effectiveness and safety profile of terlipressin in this patient population with urgent unmet medical needs,” said study lead investigator Arun Sanyal, MD.
Mallinckrodt plans to submit a New Drug Application for terlipressin in early 2020.
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