Date: 2012-03-30
Type of information: Results
phase: 3
Announcement: results
Company: Shire (UK-USA)
Product: SPD476, MMX® mesalamine
Action
mechanism: SPD476, MMX mesalamine is an anti-inflammatory drug, with each delayed-release tablet containing 1.2g of 5-aminosalicylic acid (5-ASA; mesalamine). In the U.S., SPD476, MMX mesalamine is registered as Lialda® (mesalamine) and is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. In Europe, it is registered as Mezavant®/Mezavant XL® and is approved for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis and for maintenance of remission. SPD476, MMX mesalamine should be taken once daily with food
Disease: diverticulitis
Therapeutic area: Digestive diseases
Country:
Trial
details: The PREVENT investigational program consists of two trials, PREVENT1 and PREVENT2. These are phase 3, randomized, double-blind, dose-response, stratified, placebo-controlled studies with an identical design. PREVENT2 randomized 592 subjects to receive once-daily SPD476, MMX mesalamine 1.2g, 2.4g or 4.8g, or placebo, over a period of 104 weeks.
The objective of the PREVENT2 investigational study was to evaluate the safety and efficacy of SPD476, MMX mesalamine versus placebo in reducing the incidence of recurrent attacks of diverticulitis in patients with a history of at least one prior attack.
The primary efficacy measure was the proportion of patients without a recurrence of diverticulitis between three doses of SPD476, MMX mesalamine and placebo at week 104. Recurrence of diverticulitis was defined as:
1) the presence of each and all of the following three items: abdominal pain, a 15% increase in white blood cell count from baseline, and bowel wall thickening (>5mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan, or
2) surgical intervention for diverticular disease. The key secondary endpoint evaluated recurrence based on CT scan only.
Latest
news: Shire has announced top-line results of the PREVENT2 trial, a phase 3 investigational study of once-daily SPD476, MMX® mesalamine in patients with a history of diverticulitis. The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a 2-year treatment period. In addition, SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study.
Shire will continue to analyze these data and those of a second study,PREVENT1. However the company should not pursue a regulatory filing for this indication for MMX® mesalamine. The PREVENT1 trial results are expected later this year.
