PRISM Study-Pruritus Relief Through Itch Scratch Modulation

This is a randomized, double-blinded, placebo-controlled, 2-arm study with an open label
extension period following double-blind treatment, to investigate the anti-pruritic efficacy
and safety of Nalbuphine ER tablets. Subjects will be randomized to NAL ER (2-week titration
followed by 162 mg twice daily [BID] for 12 weeks) or matching placebo (14 weeks duration),
with the primary endpoint evaluation at Week 14. During the open label extension, subjects
who received NAL ER will continue on NAL ER total treatment duration 52 weeks including
titration and subjects who received placebo will crossover to Nalbuphine ER Upon
discontinuation of investigational product, all subjects will complete a 2-week off treatment
Safety Follow-up Period, regardless of when and why the subject discontinued study treatment.

Inclusion Criteria:

1. Individuals diagnosed with generalized nodular PN

2. Severe itch due to PN

3. Age 18 years and older at the time of consent, and a life expectancy of at least 18
months.

Exclusion Criteria:

1. Pruritus due to localized PN (only one body part affected)

2. Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic
dermatitis, bullous pemphigoid for example) or other dermatologic conditions that in
the opinion of the Investigator could confound the ability to assess PN related itch..

3. Exposure to any investigational medication, including placebo, within 4 weeks (3
months for biologics).