On March 30, 2012, Shire plc announced results of the PREVENT2 trial, a phase 3 investigational study of Lialda (mesalamine). The goal of the PREVENT2 study was to evaluate the safety and efficacy of Lialda versus placebo in reducing the incidence of recurrent attacks of diverticulitis (diverticular Inflammation).
The study showed, however, that Lialda proved no better than a placebo in reducing the rate of recurrence of diverticulitis. Shire announced that they will not pursue a regulatory filing for this new indication for Lialda.
Analysis:
Lialda (mesalamine) is an anti-inflammatory drug indicated for the induction and maintenance of remission in patients with active, mild to moderate ulcerative colitis (UC), a form of inflammatory bowel disease (IBD). Lialda was FDA approved on January 16, 2007.
Using data from AERS, from 01/16/2007 to 9/30/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 692 total patients who experienced a serious adverse event where Lialda was identified as a suspect drug causing the event and 254 patients who experienced a serious adverse event where Lialda was identified as the primary suspect.
The most commonly reported side effects were pancreatitis (inflammation of pancreas), pyrexia (fever), and ulcerative colitis. We identified 105 hospitalizations and 10 patient deaths where Lialda was identified as the primary suspect.
