PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals Inc. today announced the launch of ORTIKOS™ (budesonide) in the United States, which 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 8 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.1 ORTIKOS is now available by prescription in 6- and 9-mg doses.1 The announcement marks Ferring’s second addition to its growing gastroenterology portfolio this month for the treatment of Crohn’s disease.
“Patients with Crohn’s disease are seeking not only safe and efficacious treatments that can provide incremental improvement, but also convenient options when managing this chronic condition,” said Dr. Miguel Regueiro from the Cleveland Clinic. “The availability of ORTIKOS addresses the needs of patients, helping to treat and maintain clinical remission with one pill per day.”
The safety and efficacy of ORTIKOS has been established based on clinical studies of another oral budesonide.1 Patients taking budesonide also experienced fewer glucocorticosteroid (GCS)-related side effects in 8 weeks than prednisolone.1 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.1
“With the availability of ORTIKOS once-daily therapy, Ferring is now offering treatments for every stage of Crohn’s disease,” said Brent Ragans, President of Ferring US. “This is an important milestone for our company that speaks to our commitment to improving the lives of people living with Crohn’s disease and aligns with our efforts to advance gastroenterology treatments.”
Healthcare providers may call their local pharmacies to confirm that ORTIKOS is in stock. Commercial patients may pay as little as $10 for a 30-day supply of ORTIKOS. For additional information, including terms and conditions, please visit ORTIKOS.com or www.FerringUSA.com.
ORTIKOS™ (budesonide) is an anti-inflammatory corticosteroid (extended-release capsule) and has a high glucocorticoid effect and a weak mineralocorticoid effect.1 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.1
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 8 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 3 months in adults.1
About Crohn’s disease
Crohn’s disease is an inflammatory bowel disease causing chronic inflammation of the gastrointestinal (GI) tract.3 Crohn’s disease can affect any part of the GI tract from mouth to anus, most commonly involving the ileum and proximal colon.2 It belongs to a group of conditions known as inflammatory bowel diseases, or IBD.4 The disease can occur at any age, but is most often diagnosed in adolescents and adults between the ages of 20 and 30.3 Approximately 800,000 Americans are currently affected by Crohn’s disease.2
Patients with Crohn’s disease may present acutely or have a history of symptoms prior to confirming diagnosis.2 A hallmark symptom in patients with Crohn’s disease is abdominal pain.2 Other symptoms include diarrhea potentially persistent in nature, GI bleeding, urgent need to move bowels, abdominal cramps, sensation of incomplete bowel evacuation and constipation, which can lead to bowel obstruction.2
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and orthopaedics. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com
IMPORTANT SAFETY INFORMATION
ORTIKOS is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of the capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred.
WARNINGS AND PRECAUTIONS
- Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids, pediatrics, and patients with hepatic impairment may be at increased risk. Pediatric patients with Crohn's disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression. Avoid use of Ortikos in patients with moderate or severe hepatic impairment.
- Symptoms of Steroid withdrawal in Patients Transferred from Other Systemic Corticosteroids: Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema).
- Increased Risk of Infection, including Serious and Fatal Chicken Pox and Measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
- Other Corticosteroid Effects: Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma).
Most common adverse reactions (≥ 5%) in adults are: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.
Avoid use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) as they can increase systemic budesonide concentrations.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ORTIKOS is a trademark of Sun Pharma Global FZE.
- ORTIKOS [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.
- Crohn’s & Colitis Foundation. The Facts About Inflammatory Bowel Diseases. November 2014.
- Crohn’s & Colitis Foundation. Living with Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/living-with-crohns-disease.pdf. Last accessed: May 2020.
- Crohn’s & Colitis Foundation. Overview of Crohn’s Disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Last accessed: May 2020.