Javelin Pharmaceuticals has announced that Dyloject (diclofenac sodium injection) has met the primary endpoint of a linear dose-response for pain relief over six hours as measured on the Visual Analog Scale (VAS). In this Phase IIb study, patients with moderate-to-severe pain after oral surgery given a single dose of either Dyloject or Ketorolac tromethamine experienced statistically significant pain relief over 6 hours compared to patients who received placebo. Five minutes after intravenous injection, Dyloject demonstrated superior onset of pain relief to Ketorolac.

The study included 353 patients with moderate-to-severe postsurgical pain who were randomized to receive one of five dose levels of Dyloject ranging up to 75 mg, IV Ketorolac tromethamine of 30 mg, or placebo. Single doses of Dyloject showed, dose-dependent analgesic response as compared to patients given placebo, with overall analgesic effects similar to Ketorolac.