Business Wire - Dyloject™ Significantly Reduces Moderate-to-Severe Pain in Pivotal Phase 3 Orthopedic Surgical Trial
Trial Successful, Javelin Pharmaceuticals on Track to Submit New Drug Application to US FDA in 2009
CAMBRIDGE, Mass. — Javelin Pharmaceuticals (AMEX: JAV) announced today that its US product candidate Dyloject(TM) (diclofenac sodium for injection) met primary efficacy endpoints with robust statistical significance in the second of two large pivotal US Phase 3 efficacy studies in postsurgical patients with moderate-to-severe pain.
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This successful Phase 3 pivotal trial in 277 orthopedic surgical patients randomized subjects to receive one of three treatments every 6 hours: Dyloject 37.5 mg, ketorolac 30 mg, or placebo. The primary efficacy measure was the area under the curve of pain intensity across time, plotted as the difference from pretreatment pain compared to placebo. This area was examined stepwise across intervals of 0-24, 0-48, 0-72, 0-96, and 0-120 hours. Dyloject 37.5 mg had statistically significant differences compared to placebo for its primary endpoint across all five time intervals (P< 0.0001 for each of the five intervals). Dyloject’s efficacy was numerically although not statistically superior to ketorolac, which in turn was superior to placebo (P
