Budesonide

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Articles

Medicine Compliance Aid Stability

Entocort · AstraZeneca UK Ltd

AstraZeneca UK Ltd
Entocort
Capsules 3mg e/c m/r granules
A1 · Amber 1 · Stability data is available in an alternative container (not CAs) that may be extrapolated to support storage in CAs.
Airtight container
Protect from light
Protect from light and store in airtight containers. SPC states store in original packaging, which contains a desiccant. Company have stability studies that demonstrate stability in open storage for 3 months
22nd October 2015

Budenofalk · Dr Falk Pharma UK Ltd

Dr Falk Pharma UK Ltd
Budenofalk
Capsules 3mg e/c granules
A2 · Amber 2 · No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
Airtight container
Protect from light
Protect from light and store in airtight containers.
22nd October 2015

Lactation Safety Information

Inhalation

Inhalation
-
Limited published evidence of safety
Only negligible amounts in breast milk
Used in infants >1 month
18th September 2020

Intranasal

Intranasal
18th September 2020

Oral/rectal for inflammatory bowel disease

Oral/rectal
for inflammatory bowel disease
-
No published evidence of safety after oral or rectal administration
Low levels anticipated in milk due to the drug’s properties
18th September 2020

New Medicines

Jorveza · Eosinophilic oesophagitis - new 0.5mg tablet formulation

Information

Jorveza
New formulation
Dr Falk
Dr Falk

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
None
May 20 · New 0.5mg strength of the orodispersible Jorveza formulation and licence extension for maintenance therapy approved in EU [4].
Mar 20 · CHMP issues a positive opinion recommending a change to the duration of treatment allowing the use of Jorveza as maintenance therapy for eosinophilic esophagitis in adults (older than 18 years of age) with a new strength (0.5 mg orodispersible tablet). The recommendation for maintenance therapy is as follows: The recommended daily dose is 1 mg budesonide as one 0.5‑mg-tablet in the morning and one 0.5‑mg-tablet in the evening or 2 mg budesonide as one 1‑mg-tablet in the morning and one 1‑mg-tablet in the evening, depending on the individual clinical requirement of the patient. A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of esophageal inflammation in their acute disease state. The duration of maintenance therapy is determined by the treating physician [3].

Category

Oral corticosteroid in an orodispersible tablet that is designed to coat the oesophagus, enabling local anti-inflammatory action of the drug
In 2013, eosinophilic oesophagitis was considered to affect less than 5 in 10,000 people in the EU [1]. Studies suggest that the prevalence is rising, but it is uncertain whether this is a true increase or due to better diagnosis; it is most common in middle-aged men [2].
Eosinophilic oesophagitis - new 0.5mg tablet formulation
Oral

Further information

Yes
June 2021

Evidence based evaluations

Jorveza · Eosinophilic oesophagitis in children - new oral suspension formulation

Information

Jorveza
New formulation
Dr Falk
Dr Falk

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
None
Yes

Category

Oral corticosteroid in an oral suspension that is designed to coat the oesophagus, enabling local anti-inflammatory action of the drug
In 2013, eosinophilic oesophagitis was considered to affect less than 5 in 10,000 people in the EU [1]. Studies suggest that the prevalence is rising, but it is uncertain whether this is a true increase or due to better diagnosis; it is most common in middle-aged men [2].
Eosinophilic oesophagitis in children - new oral suspension formulation
Oral

Budenofalk · Microscopic colitis - in adults

Information

Budenofalk
Licence extension / variation
Dr Falk
Dr Falk

Development and Regulatory status

Launched
Launched
None
December 2019
Jan 20 · Budenofalk 3mg gastro-resistant capsules are now licensed for use in microscopic colitis, both induction and maintenance of remission (previously licensed for induction of remission of active collagenous colitis, a form of microscopic colitis) [6].
Dec 19 · Licence change approved via the EU decentralised procedure, including in the UK. The SPC has been updated with the change in indication from collagenous colitis to microscopic colitis, with consequential changes to the posology and clinical efficacy and safety section to include data on the maintenance of remission in collagenous colitis [6].
Jan 19 · Currently pre-registration in EU. Has been filed via the decentralised procedure [5].
Apr 17 · Currently in PIII trials. Will be filed in the EU using the decentralised procedure [2].

Category

Enteric coated granules containing the corticosteroid, budesonide
Microscopic colitis (MC) is a chronic inflammatory condition characterized by chronic diarrhea, normal colonic mucosa, and abnormal histologic hallmarks. Two distinct disease phenotypes exist, collagenous colitis (CC) and lymphocytic colitis (LC). Reported prevalence rates of CC and LC are 42 and 69 per 100,000 persons, respectively [1].
Microscopic colitis - in adults
Oral

Trial or other data

Sep 13 · Dr Falk Pharma in collaboration with the Swedish Organization for Studies on Inflammatory Bowel Disease completed the PIII SOIBD Collagenous Colitis Maintenance Study (SCCMS) to investigate efficacy and tolerability of budesonide gastro-resistant granule in patients with microscopic colitis. Patients underwent an 8-week induction phase followed by maintenance treatment phase (NCT01278082). The trial enrolled 92 patients in Belgium, the Czech Republic, Denmark, Germany, Hungary and Sweden [2,4].

Budenofalk · Lymphocytic colitis - induction of remission in adults, first-line (EC-coated granule formulation)

Information

Budenofalk
Licence extension / variation
Dr Falk
Dr Falk

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Enteric coated granules containing the corticosteroid, budesonide
Microscopic colitis is characterised by chronic watery diarrhoea of unknown origin. Colonoscopy shows an essentially normal colonic mucosa, however abnormal histopathology on biopsy helps establish the correct diagnosis. Collagenous colitis and lymphocytic colitis are the two major subtypes. True incidence not known.
Lymphocytic colitis - induction of remission in adults, first-line (EC-coated granule formulation)
Oral

Evidence based evaluations

Graft versus host disease (GvHD) in treatment resistant patients

Information

New formulation
Dr Falk
Dr Falk

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Jan 20 · No recent development, and not listed in Dr falk pipeline [6].

Category

Glucocorticoid receptor agonist. An oral rinse formulation that will be absorbed through the oral mucosa. This way, the product is expected to act locally, while its side effects are expected to be limited.
Immunosuppressed patients who receive white blood cells from another person are at risk of GVHD. There are approximately 25,000 HSCTs globally per year. Nearly 50% of these develop acute GVHD. There are no approved therapies for acute GVHD. Standard of care is corticosteroids as a first line agent.
Graft versus host disease (GvHD) in treatment resistant patients
Topical

Budenofalk · Ulcerative proctitis - first-line

Information

Budenofalk
New formulation
Dr Falk
Not Known

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Suppository containing the corticosteroid, budesonide
Ulcerative colitis (UC) is an idiopathic chronic inflammatory disease of the colon that follows a course of relapse and remission. In distal disease (left-sided colitis), colitis is confined to the rectum (proctitis) or rectum and sigmoid colon (proctosigmoiditis). UC has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000 [1].
Ulcerative proctitis - first-line
Rectal

Active eosinophilic oesophagitis in adults and adolescents

Information

New formulation
Takeda
Takeda

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Feb 20 · According to its latest financial results, Takeda is only developing TAK-721 for the US market [8].

Category

Oral corticosteroid in an oral suspension that is designed to coat the oesophagus, enabling local anti-inflammatory action of the drug
Eosinophilic oesophagitis affects less than 5 in 10,000 people in the EU [1].
Active eosinophilic oesophagitis in adults and adolescents
Oral

Favolir (EU), Scipe (US) · Asthma in oral corticosteroid (OCS)-dependent (GINA Step 5) adults

Information

Favolir (EU), Scipe (US)
New formulation
Vectura
Vectura

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Nov 18 · Following the failure to meet primary endpoints in the PIII study, Vectura has decided to not pursue further the development of VR47.[7]

Category

Inhaled corticosteroid delivered to the lungs via AKITA jet inhalation system, controlled by a Smart Card.
5.4 million people in the UK are currently receiving treatment for asthma: 1.1 million children (1 in 11) and 4.3 million adults (1 in 12). Tthe UK has some of the highest rates of Asthma in Europe [3].
Asthma in oral corticosteroid (OCS)-dependent (GINA Step 5) adults
Inhalation

Trial or other data

Nov 18 · PIII study of VR475 in pts with severe uncontrolled asthma did not meet its primary endpoint. There was a trend in the reduction of the annual rate of exacerbations among pts receiving either VR475 1mg or 0.5mg BD over 52-weeks vs. placebo but results did not reach statistical significance. The open label arm with conventional nebuliser also failed to reach statistical significance vs. placebo.[7]