JAVELIN REPORTS FINAL RESULTS OF POSTSURGICAL PAIN DRUG TRIAL
Javelin Pharmaceuticals has announced final results from the Phase II/III study
of Dyloject in 155 patients with moderate-to-severe postsurgical pain. In addition
to meeting the study's primary endpoints of total pain relief for four hours
and noninferiority to Voltarol, secondary endpoint results showed statistically
significant superior pain relief over the first two hours compared to Voltarol.
In the Phase II/III study, a total of 155 patients with postsurgical moderate-to-severe pain were randomized to receive a single dose of Dyloject 75-mg, Voltarol 75-mg or placebo. Dyloject provided statistically superior pain relief over Voltarol over the initial two hours post-dose as measured both on Visual Analog Scale and categorical scale. After the initial two hours post dose, both active treatment groups had similar pain relief scores that remained superior to placebo through eight hours.