Trevi Therapeutics has announced the conclusion of subject enrolment in the Phase IIb/III PRISM clinical trial of its investigational therapy Haduvio (nalbuphine ER) to treat pruritus linked with prurigo nodularis (PN).

Nearly 360 PN patients were enrolled in the trial and the company anticipates reporting top-line results in the second quarter of this year.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Haduvio is nalbuphine’s oral extended-release (ER) formulation. 

A combined ĸ-opioid and µ-opioid receptor antagonist, nalbuphine is approved and sold as an injectable for pain indications in the US and Europe for over two decades. 

The randomised, double-blind, placebo-controlled trial will analyse the safety and efficacy of Haduvio to treat severe pruritus in PN patients. 

Participants in the trial are randomised equally into two arms to receive a 162mg oral dose of Haduvio or placebo twice a day, including a preliminary blinded titration period of two weeks. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The proportion of patients attaining a greater than or equal to four-point improvement as assessed by the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at week 14 against baseline will be the trial’s primary endpoint.

Trevi Therapeutics president and CEO Jennifer Good said: “This is an important milestone in the development of Haduvio which is the lead oral compound in clinical development for pruritus in PN and which we believe may offer an important treatment option to these seriously impacted patients. 

“By targeting the pruritus associated with prurigo nodularis, Haduvio is designed to break the itch-scratch cycle which has a significant impact on patients’ quality of life.”

Earlier, nalbuphine ER obtained Fast Track designation from the US Food and Drug Administration for the proposed indication to lower moderate-to-severe pruritus in PN patients. 

Trevi Therapeutics reported positive data from a Phase II trial of oral nalbuphine ER to treat moderate-to-severe PN, in October 2016.