A Study to Evaluate the Safety and Efficacy of Topically Applied TV 45070 Ointment in Patients With Postherpetic Neuralgia (PHN)

Phase 2 Completed 300 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to evaluate the safety and efficacy of 4% and 8% w/w TV 45070 ointment compared with placebo ointment applied topically and twice daily to the area of PHN pain for 4 weeks in patients with PHN

Timeline

Start: 2015-02-26
Primary completion: 2017-05-09
Completion: 2017-05-09

Outcome

Missed primary endpoint

registry analysis (superiority test); TV-45070 4% vs Placebo; p = 0.130; LSM difference from placebo 0.32 (95% CI -0.094 to 0.726) NCT02365636 ↗

registry analysis (superiority test); TV-45070 8% vs Placebo; p = 0.245; LSM difference from placebo 0.24 (95% CI -0.167 to 0.652) NCT02365636 ↗

release “top-line results in a Phase II study of topical TV-45070 in patients with post-herpetic neuralgia (PHN). TV-45070 did not meet the primary endpoint” xenon-pharma.com ↗

Publications

Fetell M, Sendel M, Li T, Marinelli L, Vollert J, Ruggerio E, Houk G, Dockum M, Albrecht PJ, Rice FL, Baron R. Cutaneous nerve fiber and peripheral Nav1.7 assessment in a large cohort of patients with postherpetic neuralgia. Pain. 2023 Nov 1;164(11):2435-2446. doi: 10.1097/j.pain.0000000000002950. Epub 2023 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	funapide	Small molecule	4 %	Topical
Subject	funapide	Small molecule	8 %	Topical