The patient enrollment in the second of two US pivotal phase III trials for Javelin Pharmaceuticals injectable pain drug Dyloject(TM) is complete, and a New Drug Application  (NDA) is planned for the treatment of acute postoperative pain in 2009.

This pivotal study was a multi-center placebo and comparator-controlled study carried out in 242 post-operative elective orthopedic surgery patients. Efficacy in the double-blind study was measured using the Sum of Pain Intensity Differences (SPID) and measured on the 0-100 mm Visual Analog Scale (VAS). Previously, another US pivotal study evaluated Dyloject(TM) in patients suffering from moderate-to-severe postoperative pain after elective abdominal surgery.

Already marketed in the UK, the injectable form of diclofenac has proven to be superior to the traditionally-used IV formulation. The company expects to file for marketing approval through the mutual recognition process in additional EU countries during 2009.

A previous and successful study in the US evaluated the drug in patients with moderate to severe post-operative pain following elective abdominal surgery.

Source: Javelin Pharmaceuticals, Inc.