Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With …
Source: CNNMoney.com (press release) (Original Article)
BASINGSTOKE, UK and PHILADELPHIA, US June 17 /PRNewswire-FirstCall/ –
Shire Limited (LSE: SHP, Nasdaq: SHPGY), the global specialty
biopharmaceutical company, today announced the publication of data from a
randomized, long-term safety and tolerability study (study 303) of ulcerative
colitis (UC) drug Lialda(TM) (mesalamine). The primary endpoints of this
study were to assess the safety and tolerability of Lialda in mild-to-moderate
UC patients over 12 months. Data were published in the July issue of Gut, the
official journal of the British Society of Gastroenterology, a leading
international journal in gastroenterology.
"This published data demonstrates that Lialda is generally well tolerated
and has a strong safety profile," said Gary R. Lichtenstein, MD, co-author of
study 303 and director of the Center for Inflammatory Bowel Diseases at the
Hospital of the University of Pennsylvania. "Not only does this data
demonstrate Lialda’s safety and tolerability, but secondary endpoints from the
maintenance phase of the 303 study show that a majority of patients on Lialda
continued to remain in remission through 12 months."
Specifically, the primary endpoints of the Phase III, open-label, 12-month
extension study were to evaluate the safety and tolerability of Lialda dosed
once (2.4g/day) or twice daily (1.2g twice daily) over 12 months, including
adverse events (AEs), treatment exposure, and time to withdrawal. AEs refer
to any untoward medical occurrence that happens in a clinical trial patient.
AEs can be "treatment-related" (TRAEs) and occur as a result of the study drug
or they can be considered unrelated to the study drug. In study 303, all AEs
were classified in one of three categories according to severity: mild,
moderate, or severe.
Results of the study showed Lialda demonstrated a good safety profile,
with 37.9 percent of patients (safety population n=459) experiencing AEs, St George Vertigo MasterCard the
majority of which were mild …continue reading