布地奈德效果如何？

(Budesonide, Budenofalk) is a new type of inhaled glucocorticoid asthma treatment drug, which belongs to the adrenocortical hormone drugs. Budesonide (Budenofalk) was first developed and marketed by AstraZeneca Pharmaceuticals in 1981. It is a non-halogenated glucocorticoid that has a strong local anti-inflammatory effect and can inhibit early bronchospasm and late allergic reactions. It is one of the important drugs for the treatment of allergic asthma.

On December 20, 2011, Santarus Corporation of the United States announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Budesonide (Budenofalk) 9 mg (trade name: Uceris) for the induction treatment of mild to moderate ulcerative colitis. So, what is the therapeutic effect of Budesonide (Budenofalk)?

Budesonide (Budenofalk) was evaluated in two pivotal Phase III clinical studies for the treatment of patients with mildly or moderately active ulcerative colitis. In these clinical studies, patients taking Budesonide (Budenofalk) 9 mg once daily were better than placebo in achieving clinical remission as measured by the Ulcerative Colitis Activity Index (UCDAI) score in the intent-to-treat population after 8 weeks of treatment (p=0.0143 in the US study and p=0.0047 in the European study). While all randomizations were performed on patients who received at least one dose of one study drug, the intent-to-treat population was predefined in the associated statistical analysis plan.

The above-mentioned phase III clinical study results also show that (Budesonide, Budenofalk) 9 mg is generally well tolerated, and the frequency of treatment-related adverse events is similar to that in the placebo group.