Prometheus Laboratories Inc., a specialty pharmaceutical company, has announced that the US FDA has approved the supplemental New Drug Application (sNDA) for the additional use of Entocort EC (budesonide) Capsules for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to three months.

Entocort EC is the only pharmacological product indicated for the treatment of mild to moderate Crohn's disease involving the ileum and/or the ascending colon, which affects nearly 70 per cent of Crohn's patients.

Joseph M. Limber, president and CEO of Prometheus stated, "Physicians can now provide their patients with an effective long-term therapy option, in addition to an acute treatment related to mild to moderate active Crohn's disease. Our commitment is to continue to aid physicians in improving the lives of their patients through providing meaningful products and the FDA's additional approval is a significant component in keeping with that commitment."

The additional approval is based on the results of four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with either 3 mg or 6 mg Entocort EC, or placebo. The median time to relapse in the pooled population of the 4 studies was 154 days for patients taking placebo, and 268 days for patients taking Entocort EC, at 6 mg/day. Entocort EC at 6 mg/day significantly reduced the percentage of patients with loss of symptom control (28%) versus placebo (45%) in the pooled population for the 4 studies at three months, a company release said.