Santarus (SNTS) Submits UCERIS NDA to U.S. FDA
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Santarus, Inc. (Nasdaq: SNTS) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking market approval for UCERIS (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis. UCERIS, a locally acting, nonsystemic corticosteroid in a novel, patented, oral tablet formulation, utilizes proprietary MMX® multi-matrix system technology that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. UCERIS is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.
UCERIS was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III pivotal clinical studies. In these clinical studies, UCERIS 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0143 in U.S. study and p=0.0047 in E.U. study) in achieving clinical remission in the intent-to-treat (ITT) population as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. The ITT population was predefined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice violations or major entry criteria violations. The Phase III clinical study results also indicated that UCERIS 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo.
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UCERIS was evaluated for the treatment of patients with mild or moderate active ulcerative colitis in two Phase III pivotal clinical studies. In these clinical studies, UCERIS 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0143 in U.S. study and p=0.0047 in E.U. study) in achieving clinical remission in the intent-to-treat (ITT) population as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. The ITT population was predefined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice violations or major entry criteria violations. The Phase III clinical study results also indicated that UCERIS 9 mg was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo.
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