A Pipeline in a Product: Haduvio™
Trevi is developing the investigational therapy Haduvio™ (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, Haduvio™ 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 global clinical development program for Haduvio™.
Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
IPF is a rare, chronic, progressive lung disease, characterized by scarring and thickening of lung tissue; most patients diagnosed with IPF suffer from a dry, non-productive chronic cough that interrupts their daily living and significantly contributes to poor quality of life.
We are conducting a Phase 2 clinical trial of Haduvio™ for chronic cough in patients with IPF. 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 Haduvio™ for chronic cough in up to 56 patients with IPF in the United Kingdom.
scientific and clinical
posters & publications
The Role of Kappa-Opioid and Mu-Opioid Receptors in Pruritus: Peripheral and Central Itch Circuits
Kim BS et al., Exp Dermatol. (2022)
Modulation of the kappa and mu opioid axis for the treatment of chronic pruritus: A review of basic science and clinical implications
Elmariah et al., Journal of the American Academy of Dermatology (JAAD) International (2021)
Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase
Weisshaar E. et al., Journal of The European Academy of Dermatology and Venereology (2021)
Prevalence, Incidence, and Presence of Comorbidities in Patients with Prurigo and Pruritus in Germany: A Population-Based Claims Data Analysis
Augustin et al., Journal of The European Academy of Dermatology and Venereology (2021)
The Role of Kappa- and Mu- Opioid Receptors in Pruritus
as presented at Maui Derm for Dermatologists 2021
Modulation of the Mu and Kappa Opioid Axis for Treatment of Chronic Pruritus
as presented at Maui Derm for Dermatologists 2021
Prevalence of prurigo nodularis in the United States of America: A retrospective database analysis
Ständer et al., The American Academy of Dermatology (JAAD) International (2020)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus
as presented at the 2020 Fall Clinical Dermatology Conference
Efficacy and Safety of Oral Nalbuphine Extended Release in Prurigo Nodularis: Results of a Phase 2, Randomized, Controlled Trial with an Open-Label Extension Phase
as presented at the 2020 Fall Clinical Dermatology Conference
Prevalence of Prurigo Nodularis in Poland
Reich and Ryczek, Acta Dermato Venereologica (2020)
Prevalence of Prurigo Nodularis in the United States: Findings of a Retrospective Database Analysis
as presented at the 2020 AAD Annual Meeting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus
Mathur et al., American Journal of Nephrology (2017)
Nalbuphine 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).
