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News and Innovations

Javelin Pharmaceuticals announced last fall that it had completed patient enrollment in the second of two pivotal phase 3 studies for its diclofenac sodium injection (Dyloject). This trial involved moderate-to-severe postoperative pain following elective orthopedic surgery. The first successful U.S. pivotal study evaluated Dyloject in patients suffering from moderateto-severe postoperative pain after elective abdominal surgery. The Company announced plans to file a new drug application for the treatment of acute postoperative pain in 2009. Dyloject is approved and marketed in the UK, and Javelin has announced plans to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009. This second pivotal trial enrolled 242 postoperative elective orthopedic surgical patients. It was multicenter, placeboand comparatorcontrolled. The patients were randomized to receive ketorolac 18.75, 37.5, or 50 mg IV every 6 hours, ketorolac 15 or 30 mg IV every 6 hours, or IV placebo. Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to 5 days. The primary measure of efficacy was the sum of pain intensity differences (SPID) as measured on the 0100-mm visual analog scale (VAS).