Ferring Pharmaceuticals announced the launch of Ortikos™ (budesonide) extended-release capsules.

Ortikos, an anti-inflammatory corticosteroid, is approved as a once-daily treatment for mild to moderate active Crohn disease involving the ileum and/or the ascending colon, in patients aged 8 years and older. It is also indicated for maintenance of clinical remission involving the ileum and/or the ascending colon for up to 3 months in adults.

The safety and efficacy of Ortikos were established in multiple clinical studies evaluating another oral budesonide product in patients with Crohn disease.  Two of these studies compared oral budesonide to oral prednisolone in adult patients with mild to moderate active Crohn disease. In both studies, clinical improvement was defined as a Crohn Disease Activity Index score of 150 assessed after 8 weeks of treatment. Results showed equal rates of clinical improvement (60%) in both groups in the first study, while in the other, 13% fewer patients in the budesonide group experienced clinical improvement (52% vs 65% with prednisolone).   

The most common adverse reactions (≥5%) with budesonide therapy include headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue and pain.


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Ortikos is supplied as 6mg and 9mg extended-release capsules in 30-count bottles. Ferring is offering a copay savings card to assist patients.

For more information visit ortikos.com.

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References:

1. ORTIKOS™ (budesonide), the first and only once-daily dose for treatment of mild to moderate Crohn’s disease, now available in the US. https://www.businesswire.com/news/home/20200729005225/en/ORTIKOS%E2%84%A2-budesonide-Once-Daily-Dose-Treatment-Mild-Moderate. Published July 29, 2020. Accessed July 29, 2020. 

2. Otrikos [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2020.

This article originally appeared on MPR