Lialda mesalamine: Phase III data
Top-line data from the double-blind, international Phase III PREVENT2 trial in 592 patients showed that once-daily SPD476 missed the primary endpoint vs. placebo of a greater proportion of patients without recurrence of diverticulitis at week 104. Recurrence was defined as abdominal pain, a 15% increase in white blood cell count from baseline, and bowel wall thickening >5 mm and/or fat stranding as evidenced by spiral CT scan; or surgical intervention for diverticular disease. SPD476 also missed the secondary endpoint of a greater proportion of patients without recurrence as evaluated only by CT scan. Patients received 1.2, 2.4 or 4.8g SPD476 or placebo for 104 weeks. The identical PREVENT1 trial in the indication is ongoing with data expected later this year. However, Shire said that based on the PREVENT2 data it does not plan to pursue a regulatory application for the indication. ...