FDA Approves Once-Daily Mesalamine for Ulcerative Colitis

PHILADELPHIA, Jan. 17 -- The FDA has approved a once-daily formulation of Lialda (mesalamine) for treatment of patients with active mild to moderate ulcerative colitis, Shire PLC announced.

Each table contains 1.2 g of mesalamine, an aminosalicylate, which allows patients to control induced remission of ulcerative colitis by taking two Lialda tablets once a day. Shire will market the drug under an agreement with Giuliani S.p.A.

The company said other available mesalamines require dosing three to four times daily with as many as 16 pills a day.

Lialda utilizes MMX technology, which combines a pH dependent gastro-resistant coating to delay the release of the medication to the colon, with a tablet core containing mesalamine with hydrophilic and lipophilic excipients.

The approval of Lialda was predicated on the results of two phase III clinical studies.

The first assessed the efficacy and safety of Lialda in 262 patients at 2.4 g/day given in divided doses twice daily, or 4.8 g/day given once daily, against placebo. At eight weeks, 34.1% of the patients taking 2.4 g/day achieved remission, as did 29.2% of those assigned to the higher dose, versus a 12.9% remission rate in the placebo arm.

The second trial assessed the safety and efficacy of the 2.4 g/day and the 4.8 g/day doses given once a day versus placebo. At eight weeks both doses were superior to placebo with a 40.5% induction of remission in the 2.4 g/day dose and a 41.2% remission for the higher dose versus 22.1% with placebo.

Safety and efficacy have not been assessed for periods longer than eight weeks.

In clinical trials the drug was generally well tolerated. The most common treatment-related adverse events with Lialda were headache (5.6% with low dose and 3.4% with the higher dose) and flatulence (4% with the low dose, 2.8% with the higher dose). Caution when prescribing Lialda was recommended for patients with impaired hepatic or renal function.