Ferring Pharmaceuticals announced today that its Cortiment MMX (budesonide) treatment for the induction of remission in patients with active, mild to moderate ulcerative colitis has received marketing approval from 27 European Union member states following the EU Mutual Recognition Procedure. Cortiment has been commercially available in the Netherlands since November 2013. Ferring plans to begin launching the product in the 27 additional European countries in the coming months.

Coetiment contains budesonide, a locally acting glucocorticosteroid, in a novel oral tablet formulation utilizing MMX multimatrix colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks. In phase III studies, 2.4 to 3.9 times more patients achieved clinical and endoscopic remission with Cortiment compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I study and CORE II study respectively).

Cortiment has been developed by Cosmo Pharmaceuticals SpA. Ferring is the licensee in the EU and Asia (excluding Japan), Australia, Canada, Latin America and Africa. In the United States, where the product is available as Uceris, the licensee is Salix Pharmaceuticals, Inc.

For more details, go to: https://www.ferring.com/en/media/press-releases/2014/cortiment-european-approval-20-oct-14/