Javelin Pharmaceuticals Begins Second Phase III Study of Dyloject
Javelin Pharmaceuticals announced that three patients began treatment in the second of two planned Phase III clinical studies for its injectable nonsteroidal anti-inflammatory drug, Dyloject.
According to Javelin, the U.S. study will enroll patients with moderate-to-severe postoperative pain following elective orthopedic surgery.
A total of 240 patients will be randomized in this multicenter, placebo- and comparator-controlled study. They will receive either a 18.75-, 37.5- or 50-mg dose of Dyloject (injectable diclofenac sodium) intravenously, a 15- or 30-mg dose every six hours of ketorolac intravenously or placebo intravenously, the company said.
Subjects will eligible for treatment for up to five days, according to the company.
Patient enrollment was also recently completed in the first pivotal Phase III study of patients with postoperative pain after elective abdominal surgery, and an announcement of top-line results is expected by the end of the year, the company added.