Strong Ph III data on Javelin's Dyloject

The USA's Javelin Pharmaceuticals has presented new and successful secondary endpoint data from a previously announced pivotal Phase III study of its injectable diclofenac formulation, Dyloject, at the 12th World Congress on Pain, held in Glasgow, Scotland.

According to the mid-stage findings, the agent offers safe, efficacious and well-tolerated pain relief for abdominal and pelvic surgery. Patient global evaluation scores and related measures of efficacy at 24 and 48 hours were statistically significantly higher than placebo for all three arms of the study: Dyloject 18.75mg and 37.5mg and the active comparator ketorolac 30mg. Compared to the ketorolac group, the Dyloject groups had a lower incidence of thrombophlebitis, and numerically fewer adverse events associated with postoperative bleeding.

Dyloject given IV in clinically-relevant analgesic doses to healthy volunteers in a Phase I study produced minimal interference with platelet function (ability to clot), reaching only the upper limit of normal. Similar small effects were seen with an oral diclofenac comparator, Cataflam. In contrast, IV ketorolac and oral aspirin markedly disrupted platelet function