other material
confidence high
sentiment neutral
materiality 0.60
Trevi completes enrollment in Phase 2b/3 PRISM trial for Haduvio in prurigo nodularis; top-line data expected Q2 2022
Trevi Therapeutics, Inc.
- PRISM trial enrolled ~360 subjects with severe pruritus and prurigo nodularis.
- Trial evaluates Haduvio (nalbuphine ER) 162 mg versus placebo twice daily.
- Primary endpoint: ≥4-point improvement in weekly mean WI-NRS at Week 14 vs baseline.
- FDA previously granted Fast Track designation for nalbuphine ER in PN pruritus.
- Top-line data expected in Q2 2022.