The initiation of this single-arm open label observational safety study follows a successful pivotal Phase III study of Dyloject in patients with postoperative abdominal pain. Additionally, the company plans to report top-line data later this year from a second pivotal phase III study, evaluating Dyloject in patients with postoperative orthopedic pain.
The study will enroll up to 700 male and female patients from age 18-85 in an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of Dyloject in patients with acute post-operative pain following abdominal or orthopedic surgery.
Patient global assessment will be obtained at study discharge or early termination. Patients will receive Dyloject for a minimum of 48 hours and until they are transitioned to oral analgesics, discharged from the institution, received a maximum of five days of treatment with Dyloject or discontinued from the study which ever comes first.
The study is intended to supplement the company’s summary of integrated patient safety data base, a part of its new drug application for Dyloject in the US, planned for submission to the FDA in 2009.