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news.To evaluate safety, following IV bolus administration of multiple doses over multiple days in patients with acute post-operative pain
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Javelin Pharmaceuticals (Javelin) has completed open-label, multi-dose, multi-day, observational safety study of Dyloject in the US, and has announced that it has successfully met its objective. The company also plans to file a New Drug application (NDA) for Dyloject in the US.
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.
Eric Lang, Vice President of Clinical Research, Javelin, said: We were very pleased that the study met its objective and finished ahead of schedule. 856 patients successfully completed the study, receiving at least 8 doses of Dyloject. Javelin now has comprehensive safety data on greater than 1700 patients in our Integrated Summary of Safety for our NDA submission. We are on track to file a high quality NDA for Dyloject this fall.