31 July 2020 - - US-based specialty biopharmaceutical group Ferring Pharmaceuticals Inc. has launched Ortikos (budesonide) in the United States, the group said.

Ortikos is approved as the only once-daily treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients eight years of age and older, and maintenance of clinical remission in adults involving the ileum and/or the ascending colon for up to three months.

Ortikos is now available by prescription in 6- and 9-mg doses.

The announcement marks Ferring's second addition to its growing gastroenterology portfolio this month for the treatment of Crohn's disease.

The safety and efficacy of Ortikos has been established based on clinical studies of another oral budesonide.

Patients taking budesonide also experienced fewer glucocorticosteroid -related side effects in eight weeks than prednisolone.

The most common reported adverse reactions (≥5 percent) with budesonide in adults were: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue and pain.

Healthcare providers may call their local pharmacies to confirm that Ortikos is in stock.

Commercial patients may pay as little as USD 10 for a 30-day supply of Ortikos.

Ortikos (budesonide) is an anti-inflammatory corticosteroid (extended-release capsule) and has a high glucocorticoid effect and a weak mineralocorticoid effect.

The affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.

Ortikos is approved for the treatment of symptoms of mild to moderate Crohn's disease involving the ileum and/or the ascending colon, in patients eight years of age and older, and maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to three months in adults.