Javelin Pharmaceuticals announced that it has completed its observational safety study of Dyloject (diclofenac sodium) for the treatment of patients with acute post-operative pain. This study was an open-label, multi-dose, single-arm safety study of repeat-doses of Dyloject 37.5 or 50 mg doses over multiple days in patients aged 18 to 85 with acute post-operative pain following abdominal (eg, non-laparoscopic abdominal surgeries) or orthopedic (eg, hip or knee joint replacement) surgery. 856 patients successfully completed the study, receiving at least 8 doses of Dyloject over two days of therapy. The study’s successful completion satisfies Javelin’s goal to establish a patient safety data base for its Dyloject US New Drug Application (NDA) projected fall of 2009 filing.
Dyloject is an injectable formulation of diclofenac, a prescription NSAID that is widely prescribed to treat postoperative pain.
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