Trevi reports Phase II/III uremic pruritus data

Trevi Therapeutics Inc. (New Haven, Conn.) said the 120 mg dose of oral nalbuphine ER ( T111) met its primary endpoint of reducing itch intensity compared to placebo in a Phase II/III trial to treat moderate to severe uremic pruritus in patients on hemodialysis.

The trial showed that twice-daily 120 mg doses of nalbuphine ER led to a mean reduction of 3.5 points in itch intensity from baseline over the eight-week treatment period (p=0.017). Itch intensity was measured on a 10 point itch numerical rating scale (NRS). The 60 mg dose of nalbuphine ER did not significantly reduce itch intensity vs. placebo. ...