Nalbuphine ER: Phase II/III data

A double-blind, international Phase II/III trial in about 370 patients on hemodialysis with moderate to severe uremic pruritus showed that twice-daily 120 mg oral Nalbuphine ER for 6 weeks met the primary endpoint of reducing mean NRS itch score from baseline to week 7 and 8 vs. placebo. Specifically, 120 mg Nalbuphine ER reduced mean NRS itch score by 3.5 points from baseline to weeks 7 and 8 vs. an undisclosed change for placebo (p=0.017). The twice-daily 60 mg dose of Nalbuphine ER missed the primary endpoint vs. placebo. In patients with severe itch at baseline, defined as an NRS score of >=7 points, high-dose Nalbuphine ER significantly reduced mean NRS itch score by 4.5 points from baseline to week 7 and 8 vs. an undisclosed change for placebo (p=0.007). ...