A Pipeline in a Product: Nalbuphine ER
Trevi is developing nalbuphine ER in a range of indications for which patients have few treatment options. With its dual mechanism of action, acting as both an antagonist (blocker) to the mu opioid receptor and as an agonist (activator) to the kappa opioid receptor, nalbuphine ER has the potential to significantly improve the quality of life of patients suffering from serious neurologically mediated conditions by targeting the central and peripheral nervous systems.
We are conducting a rigorous global clinical development program for nalbuphine ER.

Prurigo Nodularis (PN)
In September 2018, we initiated our pivotal Phase 2b/3 PRISM (Pruritus Relief thru Itch-Scratch Modulation) clinical trial evaluating the safety and efficacy of nalbuphine ER in patients with severe pruritus associated with PN.
The PRISM trial is a randomized, double-blind, placebo-controlled, parallel, two-arm, 14-week treatment study that is evaluating the safety and anti-pruritic efficacy of nalbuphine ER 162 mg tablets in 240 patients at approximately 50 sites in the United States and Europe.
We are now enrolling patients in the U.S. (NCT number: NCT03497975) and in the EU.
Pruritis in Chronic Liver Disease
A Phase 1b open label study is underway to determine the safety and pharmacokinetics of nalbuphine ER in patients with moderate to severe chronic liver disease.
Uremic Pruritus (UP)
We are not actively developing nalbuphine ER for uremic pruritus at this time based on our evaluation of the market dynamics, but may consider resuming development in the future.
Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
We initiated a Phase 2 clinical trial of nalbuphine ER for chronic cough in patients with IPF in June 2019. The Phase 2 trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in up to 56 patients with IPF in the United Kingdom.
Levodopa-induced Dyskinesia (LID) in Patients with Parkinson’s Disease
Subject to discussions with the FDA and the submission of an IND for this indication, we intend to initiate a Phase 2 trial of nalbuphine ER in the second half of 2019 to evaluate the effect of nalbuphine ER on LID in patients with Parkinson’s disease.
scientific and clinical
posters & publications
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus
Mathur et al., American Journal of Nephrology (2017)
ER Tablets in Hemodialysis Patients with Severe Uremic Pruritus: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
as presented at the National Kidney Foundation Spring 2016 Meeting.
Long-Term Effects of Nalbuphine ER Tablets in Hemodialysis Patients with Uremic Pruritus: A Multicenter Open-Label Trial
as presented at the National Kidney Foundation Spring 2016 Meeting.
Pharmacokinetics of nalbuphine hydrochloride extended release tablets in hemodialysis patients with exploratory effect on pruritus
Hawi, et al, BMC Nephrology (2015)
Pharmacokinetics of nalbuphine hydrochloride proof-of-concept study with pharmacokinetics demonstrating anti-pruritic activity of oral nalbuphine in hemodialysis patients with uremic pruritus
as presented at the 2014 Meeting of the Society for Investigative Dermatology.
Pharmacokinetics of Nalbuphine Hydrochloride Extended Release Tablets in Hemodialysis and Healthy Subjects following Multiple Escalating Oral Doses
as presented at the 2014 Meeting of the American College of Pharmacology.
Exploring Clinical and Pharmacological Effects of Nalbuphine HCl Oral Tablets in Hemodialysis Subjects with Pruritus
as presented at American Society of Nephrology’s 2014 Kidney Week.
Nalbuphine attenuates itch in the substance P-induced mouse model
as presented at 7th World Congress on Itch (2013).