JAVELIN REPORTS RESULTS FROM POST-SURGICAL PAIN STUDY

Javelin Pharmaceuticals has presented final results of its U.S. Phase IIB study of Dyloject, a proprietary formulation of diclofenac for injection, tested in 353 patients with moderate-to-severe post-surgical pain. In addition to meeting the primary endpoint of a linear dose-response for pain relief over six hours, the study demonstrated that each of the five doses tested (3.75 through 75 mg) separated statistically from placebo.

Each patient received a single bolus intravenous injection of Dyloject (3.75, 9.4, 18.75. 37.5 or 75 mg), ketorolac (30 mg) or placebo. Results showed Dyloject's analgesic effect occurred as early as five minutes post-injection, extending a prior study that found Dyloject gave pain relief more quickly than Voltarol. Analysis of the data did not reveal unexpected safety signals in either the Dyloject or ketorolac treatment arms. The incidence of surgical-site bleeding in the ketorolac group was over twice that seen in any of the Dyloject groups.

Dyloject is currently in development in the U.S. for the treatment of acute moderate-to-severe pain. Javelin has filed a marketing authorization application for the drug in Europe. Earlier studies demonstrated Dyloject to be safe and well-tolerated (including evidence for a lower incidence and severity of vein irritation than Voltarol, the currently marketed European formulation of injectable diclofenac).