In the past, budesonide has been used in a number of therapeutic indications, such as to reduce proteinuria in IgA nephropathy or digestive tract inflammation in those with Crohn’s disease. The corticosteroid, which inhibits immune response and has anti-inflammatory properties, is also used to treat inflammation in ulcerative colitis (UC). Both UC and Crohn’s disease exist under the greater umbrella of inflammatory bowel disease (IBD). Healio recently reported that the U.S. Food and Drug Administration (FDA) approved an abbreviated New Drug Application (NDA) for generic budesonide 2mg rectal foam. This therapy is designed to induce remission in mild-to-moderate UC.
Budesonide rectal foam is applied directly to the rectum. It works to reduce pain and inflammation. Many people can expect to see results from treatment within 1-2 weeks, although it may take longer in other cases. Researchers are not yet sure if budesonide rectal foam is safe or effective for children living with UC. So, for now, the therapy will be used in adults until more research can be done. The treatment has been proven to be safe and effective in adults. However, some side effects may occur. These may include nausea, adrenal insufficiency, and lower blood cortisol levels.
At this time, the FDA has shared that generic budesonide rectal foam is a therapeutic equivalent to Uceris, another rectal foam product.
Learn More About Ulcerative Colitis (UC)
Ulcerative colitis is a chronic inflammatory disease that causes the formation of ulcers and sores in the large intestine. There are multiple subtypes of ulcerative colitis, such as ulcerative proctitis, proctosigmoiditis, pancolitis, and left-sided colitis; disease presentation may differ depending on subtype. While the exact cause of this disease is unknown, some believe that an immune malfunction may play a role. Diet and stress may exacerbate symptoms. People are more likely to develop ulcerative colitis if they are under 30 or over 60, related to someone with IBD, or of Ashkenazi Jewish heritage. Symptoms may, but do not always, include:
- Nausea
- Unintended weight loss
- Anemia (low red blood cell count)
- Persistent diarrhea
- Bloody stool
- Abdominal pain and cramping
- Joint pain
- Rectal pain and bleeding
- Failure to grow (in children)
Managing ulcerative colitis may require a multidisciplinary approach and/or a combination of therapies designed to:
- Control and reduce symptoms
- Prompt remission
People with UC may be prescribed biologic therapies, corticosteroids, antibiotics, aminosalicylates, and immunomodulators. If you have UC, speaking with your care team will identify your best course of treatment.
