FDA approves Delzicol to treat ulcerative colitis

The FDA has approved Delzicol as a treatment for ulcerative colitis, according to a press release.

Delzicol (mesalamine, Warner Chilcott) is intended to treat mild-to-moderate ulcerative colitis (UC) and maintenance of remission. The drug will be available in 400-mg, delayed-release capsules, with an approved dosage of 800 mg three times a day for treatment and a divided dose of 1.6 g per day for maintenance of remission, according to the release. The company will launch Delzicol commercially during March.

Approval for Delzicol followed two placebo-controlled studies assessing its use as a treatment for UC, in which divided daily doses of 2.4 g and 4.8 g resulted in significant improvement to the sigmoidoscopic appearance of the bowel compared with placebo.

The approval for its use in maintenance of remission followed a 6-month, double blind, randomized study in which a divided 1.6-g daily dose maintained remission in significantly more participants than placebo, as well as a pooled analysis of four trials in which Delzicol performed similarly to sulfasalazine.

According to the prescribing information, Delzicol is contraindicated for patients who are hypersensitive to aminosalicylates or salicylates. Common adverse events associated with Delzicol include abdominal and back pain, eructation, rash and dyspepsia. Potential serious reactions include renal impairment/failure, exacerbation of colitis and liver failure.