Shire Announces Top-line Results of Prevent2 Phase-III Trial of MMX Mesalamine
Shire has revealed that it does not plan to pursue a regulatory filing for MMX mesalamine in patients with a history of diverticulitis, after the drug failed to meet the primary endpoint in a recent phase-III study.
Biopharmaceutical company Shire has announced top-line results from a phase-III clinical trial involving its once-daily anti-inflammatory drug, SPD476, MMX mesalamine.
The study was conducted in ten countries and aimed to evaluate the safety and efficacy of SPD476, MMX mesalamine in patients with a history of diverticulitis.
Researchers designed the trial to see whether the investigational therapy was more effective than placebo at reducing the incidence of recurrent attacks of diverticulitis.
The study did not meet its primary endpoint - reducing the rate of recurrence over a two-year period - and did not show a significant difference on the main secondary endpo
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