A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

Summary

The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01 treated subjects.

Timeline

Start

2008-08

Primary completion

2009-03

Completion

2009-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sufentanil NanoTab 10 mcg vs Placebo NanoTab; p <0.001; Mean Difference (Final Values) 19.48; ANCOVA NCT00718081 ↗

release “Study in major abdominal surgery patients achieved primary and secondary endpoints” talphera.com ↗

Publications

• Results Minkowitz HS, Singla NK, Evashenk MA, Hwang SS, Chiang YK, Hamel LG, Palmer PP. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):131-9. doi: 10.1097/AAP.0b013e3182791157.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	10 ug	Oral
Subject	Sufentanil	Other / unclassified	15 ug	Oral

Indications

No indication recorded.