Weisshaar E, Szepietowski JC, Bernhard JD, et al. - Findings demonstrate that measurable anti-pruritic efficacy was conferred by oral treatment with nalbuphine extended release (NAL-ER) 162 mg twice daily in adult patients with prurigo nodularis (PN) who completed ≥10 weeks of treatment and this treatment regimen was well tolerated.

• A phase 2, multicenter, randomized, double-blind, placebo-controlled trial with an open-label, 50-week extension phase to assess efficacy and safety of two oral doses of the kappa opioid agonist and mu opioid antagonist NAL-ER tablets.

• Moderate-to-severe PN patients were randomly assigned to NAL-ER 81 mg (NAL-ER81) or 162 mg (NAL-ER162) tablets twice-daily or placebo for 8 weeks of stable dosing following a 2-week titration span.

• ≥30% reduction from baseline in 7-day Worst Itch Numerical Rating Scale at Week 10 (primary efficacy endpoint) was achieved in 44.4% of patients treated with NAL-ER162 and 27.3% treated with NAL-ER81 vs 36.4% in the placebo group.

• Significant itch reduction was achieved in 66.7% of those completing Week 10 treated with NAL-ER162 vs placebo (40.0%).

• Further improvements in itch reduction and favourable changes in PN lesion activity were observed in relation to extended open-label treatment.

• Mild-to-moderate severity adverse events occurred mainly during dose titration, and no change occurred in safety profile with extended open-label treatment.