Javelin Pharma (JAV) Completes Open-Label Multi-Dose, Multi-Day Safety Study of Dyloject(TM)
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Javelin Pharmaceuticals, Inc. (Amex: JAV) today reported that it has completed its open-label multi-dose, multi-day, observational safety study of Dyloject in the United States and that the study successfully met its objective.
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. 856 patients successfully completed the study, receiving at least 8 doses of Dyloject over a 48 hour period. As with previous trials, Javelin plans to submit the results of this study for publication and presentation at an upcoming medical meeting.
The successful completion of this study satisfies the Company's goal of having well in excess of a 1000-patient safety data base for its Dyloject US NDA filing. The Company plans to file a New Drug application for Dyloject in the United States in the fall of 2009, at the same 37.5 mg dose used in the study.
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