This pivotal US study will enroll 360 patients with moderate-to-severe postoperative pain following abdominal surgery. A second study in a different postoperative pain model (orthopedic surgery) is planned to begin later this year.
This study follows the successful completion of a 353 patient phase IIb study of Dyloject in patients with postoperative pain. Javelin’s phase II studies of this nonselective NSAID showed it to be well tolerated, with a quicker onset, equal duration of effect, and less associated phlebitis than Voltarol, the injectable diclofenac formulation currently marketed in Europe.
An application to market Dyloject was filed last fall in Europe. Results of the latest phase IIb study have been submitted for presentation at the annual meeting of the European Federation of IASP Chapters in September 2006.
“Javelin has now commenced enrollment in phase III programs for two of its three product candidates this month,” said Dr Daniel Carr, the Javelin CEO and chief medical officer.
“As with our other phase III program for the intranasal morphine product Rylomine, in both cases a productive end-of-phase II meeting with the FDA allowed us to define a straightforward path to regulatory approval.”
The 360 lower abdominal surgery patients will be randomized in this multi-center, double-blind, placebo- and comparator-controlled study.