Budesonide Once-daily Pill Now Available in US for Crohn’s Disease

Budesonide Once-daily Pill Now Available in US for Crohn’s Disease

Ferring Pharmaceuticals has announced the launch of Ortikos (budesonide), the first and only once-daily pill treatment for people, 8 and older, with mild to moderate Crohn’s disease, in the U.S.

With Ortikos, budesonide is now available in 9 and 6 mg extended-release capsules, the recommended total daily dosages for the induction and maintenance of remission of mild to moderate Crohn’s disease involving the ileum (the final section of the small intestine) and/or the initial part of the colon.

Healthcare providers can check with their local pharmacies if Ortikos is in stock. Patients may pay the discounted rate of $10 for a 30-day supply through Ferring’s copay savings card.

“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,” Miguel Regueiro, MD, of the Cleveland Clinic, said in a press release.

“The availability of Ortikos addresses the needs of patients, helping to treat and maintain clinical remission with one pill per day,” he added.

The recommended dosage of budesonide extended-release capsules — such as Ortikos and Entocort EC — for treatment initiation is 9 mg once daily for up to eight weeks in individuals age 8 or older, followed by 6 mg once-a-day for two weeks in pediatric patients.

For maintenance of clinical remission in adults, 6 mg daily up to three months is the recommended dosage.

Entocort EC (sold by Perrigo) is only available in 3 mg capsules, thus requiring two to three capsules to achieve the recommended dosage. Ortikos, originally developed by Sun Pharmaceutical, requires a single pill per day.

Approved in July 2019, Ortikos’ safety and effectiveness were based on clinical data of Entocort EC in people with Crohn’s disease.

Budesonide is a corticosteroid, the most common treatment for inflammatory bowel disease (IBD), including Crohn’s and ulcerative colitis. It works to reduce inflammation and symptoms of IBD.

The treatment’s potency is about 15 times greater than that of prednisolone, a conventional corticosteroid used for Crohn’s.

In addition, clinical studies showed that eight-week treatment with Entocort EC was associated with a reduced risk of side effects, compared with oral prednisolone. This is due to budesonide’s local action with minimal body-wide absorption, in contrast to prednisolone’s action throughout the body.

The most common side effects (in at least 5% of patients) of budesonide treatment include headache, respiratory infection, nausea, back pain, indigestion, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.

“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 U.S.

“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,” he added.

Ortikos is the latest addition to Ferring’s growing gastroenterology portfolio, following an agreement announced by the company in July to co-promote UCB’s Cimzia prefilled syringe formulation.