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.

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. 

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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.