Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

Summary

This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.

Timeline

Start

2012-10

Primary completion

2013-02

Completion

2013-02

Outcome

Met primary endpoint

registry A higher SPID-12 score is better. NCT01710345 ↗

registry analysis (superiority or other test); Sufentanil NanoTab 30 mcg vs Placebo NanoTab; p = 0.003; Mean Difference (Final Values) 13.66; ANCOVA NCT01710345 ↗

release “a placebo-controlled, dose-finding, Phase 2 study of its investigational single-dose sublingual sufentanil NanoTab for acute pain, ARX-04, successfully met its primary endpoint” talphera.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	20 ug	Subcutaneous
Subject	Sufentanil	Other / unclassified	30 ug	Subcutaneous

Indications

No indication recorded.