Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Inclusion Criteria:

• Subject has been receiving in-center hemodialysis for ≥ 3 months and are currentlyon a schedule of 3 times a week.

• Subject self-categorized themselves on the Patient Assessed Disease Severity Scaleduring Screening

• Subject meets standard of care hemodialysis efficiency guidelines during the threemonths prior to completing Screening

• Have demonstrated pruritus intensity on the Itch NRS during screening

• Male or female who are at least 18 years old at the time of Screening

Exclusion Criteria:

• Subject had a significant alteration in dialysis regimen during the Screening Period

• Subject receiving or anticipated to be receiving nocturnal dialysis or homehemodialysis treatment during the study.

• Subject has pruritus that is believed to be caused by a condition unrelated toend-stage renal disease

• Has had a history of substance abuse within 6 months prior to completing Screening

• Subject has a known drug allergy to opioids

• Subject is a pregnant or lactating female.