A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster

Summary

The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.

Timeline

Start

2007-11

Primary completion

2009-06

Completion

2009-06

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper No EPB-348 group was non-inferior to valacyclovir for time to cessation of new lesion formation or time to cessation of pain by Day 120 reads as missed primary endpoint PMID 22711350 ↗

release “Once-daily EPB-348 at two grams met its primary endpoint of non-inferiority to valacyclovir.” reads as met primary endpoint medivir.com ↗

Publications

• Results Tyring SK, Plunkett S, Scribner AR, Broker RE, Herrod JN, Handke LT, Wise JM, Martin PA; Valomaciclovir Zoster Study Group. Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: a randomized, double-blind, active-controlled trial. J Med Virol. 2012 Aug;84(8):1224-32. doi: 10.1002/jmv.23329.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Valacyclovir	Unknown	1000 mg	—
Subject	Valomaciclovir	Small molecule	1000 mg	—
Subject	Valomaciclovir	Small molecule	2000 mg	—
Subject	Valomaciclovir	Small molecule	3000 mg	—

Indications