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 currently on
a schedule of 3 times a week.

- Subject self-categorized themselves on the Patient Assessed Disease Severity Scale
during Screening

- Subject meets standard of care hemodialysis efficiency guidelines during the three
months 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 home
hemodialysis treatment during the study.

- Subject has pruritus that is believed to be caused by a condition unrelated to
end-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.