Javelin completes enrollment for second Phase III study of pain drug

This pivotal clinical study evaluated Dyloject in patients with moderate-to-severe postoperative pain following elective orthopedic surgery. A previously completed and successful US pivotal study evaluated Dyloject in patients suffering from moderate-to-severe postoperative pain after elective abdominal surgery.

A total of 242 postoperative elective orthopedic surgical patients completed this multicenter, placebo- and comparator-controlled study. They received one of three dose levels of Dyloject (18.75, 37.5 or 50mg IV every six hours), one of two dose levels of IV ketorolac (15 or 30mg every six hours), or IV placebo.

Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to five days. The primary measure of efficacy was the sum of pain intensity differences as measured on the 0-100mm visual analog scale. In this double-blinded study, patients received treatments whose identity was not known either to them or their investigators.

The company is planning to file a new drug application for the treatment of acute postoperative pain in 2009. Dyloject is being marketed in the UK and Javelin expects to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009.