New once-daily colitis drug may improve compliance


According to recent results from a Crohn's and Colitis Foundation study, 65% of patients with ulcerative colitis (UC) are poorly compliant with their medication. Now, a new therapy for the condition with once-daily dosing may offer patients a better chance for compliance. In January, the Food & Drug Administration approved Lialda, from Shire plc. Lialda is a delayed-release mesalamine product that utilizes MMX technology, a pH-dependent gastro-resistant coating that delays the release of the medication until it reaches the colon, the site of the inflammation in UC.

"As you might expect, adherence to ulcerative colitis treatment is associated with better health outcomes," said Art Jacknowitz, Pharm.D., professor of clinical pharmacy at West Virginia University School of Pharmacy. "A once-daily oral formulation, compared with current treatment regimens that often require administration two to four times daily, will ensure better adherence." Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate UC.

In addition, patients with renal dysfunction should also exercise caution and use mesalamine only if the benefits outweigh the risks. Renal function should be evaluated prior to the initiation of therapy and periodically during treatment. The most common side effects reported during clinical trials included headache and flatulence.

Berardi contends that pharmacists can counsel patients to take once-daily mesalamine with a meal. "The coated tablets should not be chewed or crushed because it will cause premature release of mesalamine in the stomach, which will likely alter the effectiveness of the drug in the colon," she pointed out.

According to Shire, the company will launch Lialda in the first quarter of 2007.


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