TRVI - Trevi surges 29% as trial for pain therapy meets key goals in skin disorder

Trevi Therapeutics ( NASDAQ: TRVI ) added ~29% in the pre-market Wednesday after the clinical-stage biopharmaceutical company said that the pain therapy Haduvio met key goals in a Phase 2b/3 study involving patients with prurigo nodularis, a dermatological condition.

The double-blind study named PRISM included 168 and 176 patients who were randomized to receive Haduvio monotherapy or placebo, respectively.

At week 14, 25% of those who received Haduvio met the primary efficacy endpoint a clinical measure called 4-point reduction in the Worst Itch – Numerical Rating Scale compared to 14% in the placebo group (p=0.0157). The study also met the key secondary endpoints.

Treatment-Emergent Adverse Events (TEAE) were found in ~66% of Haduvio subjects during the double-blind titration period (weeks 1-2) compared to ~31% in the placebo arm.

While the TEAE incidence was largely similar during the 12-week fixed-dose period (48% Haduvio, 45% placebo), ~37% and ~19% patients treated with Haduvio and placebo discontinued the trial during the 14-week duration of the study, respectively.

During the 14-week double-blind portion of the PRISM study, eight on Haduvio and six on placebo developed at least one treatment emergent Serious Adverse Event (SAE). However, none of SAEs were considered to be treatment-related, according to investigators.

In 2011 Endo Pharmaceuticals ( ENDP ) partnered with Trevi ( TRVI ) to develop and market compounds incorporating nalbuphine hydrochloride. The agreement also covered extended-release formulation such as Haduvio.

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