Post-hoc and other analyses of secondary endpoints of a long-term safety and tolerability study of Shire plc's (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) ulcerative colitis (UC) drug LIALDA™ (mesalamine) provide further data on LIALDA in patients with mild to moderate ulcerative colitis.
These analyses of LIALDA’s 303 trial, a long-term, Phase III, open-label 12-14 month extension study, are being presented this week at The American College of Gastroenterology (ACG) meeting in Philadelphia.
The primary endpoint of study 303 was safety and tolerability and findings – that LIALDA is generally well tolerated in mild to moderate UC patients – were presented at the British Society of Gastroenterology (BSG) meeting in Glasgow, Scotland in March 2007.
"Earlier studies showed that LIALDA is well-tolerated and effective at inducing remission in patients with active, mild to moderate UC. Post-hoc analysis of secondary endpoints provided evidence that LIALDA maintained remission in a variety of UC patients,” said Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania.
A summary of key scientific presentations of post-hoc analyses of secondary endpoints of study 303 follows. -Shire plc
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