Javelin Pharmaceuticals has announced successfully meeting objectives during an open label, multi-dose, multi-day, observational safety study of Dyloject, a treatment for patients with acute post-operative pain.
The objective of the study was to evaluate the safety of Dyloject, following IV bolus administration of multiple doses over multiple days in patients aged 18 to 85, with acute post-operative pain.
The company now plans to file a New Drug application (NDA) for Dyloject in the US.
Javelin vice-president of clinical research Eric Lang said that 856 patients successfully completed the study, receiving at least eight doses of Dyloject.
"Javelin now has comprehensive safety data on more than 1,700 patients in our Integrated Summary of Safety for our NDA submission," Lang said. "We are on track to file a high-quality NDA for Dyloject this autumn."