Papers of the Week

Population pharmacokinetic (PK) and pharmacokinetic- pharmacodynamic (PK-PD) models were used to describe the exposure-response (E-R) relationship between nalbuphine exposure and 2 widely used rating scales for itch: the Numerical Rating Scale for the subject's 'average' itch experience (NRS-AV) and the Worst Itch (WI-NRS), with 24-hour recall. Simulations based on the model E-R relationship were used to support dose selection for Phase 3 clinical trials and were evaluated with a target of reducing the 7-day average of the 24-hour WI-NRS by at least 30% from baseline in most of the analysis population.