Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients

The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Inclusion Criteria:

• Subject suffering from generalized prurigo nodularis
• Have demonstrated pruritus intensity during screening
• Male or female who are at least 18 years old at the time of consent

Exclusion Criteria:

• Subject has chronic pruritus resulting from other conditions
• Subject has a history of substance abuse within the past year
• Subject has a known drug allergy to opioids
• Subject is a pregnant or lactating female