Budesonide

108622005

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
21st April 2017

Intranasal

Intranasal

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
19th May 2016

New Medicines

Jorveza · Eosinophilic oesophagitis (new indication and formulation)

Information

Jorveza
New formulation
Dr Falk
Dr Falk

Development and Regulatory status

Launched
Launched
None
September 2018

Sep 18: Launched in the UK. Cost for 90 x 1mg orodispersible tablets =£323.00 [6].


Jan 18: Marketing authorisation granted throughout the EU [4]


Nov 17: CHMP recommends approval for treatment of the treatment of eosinophilic esophagitis in adults [3].

Category

Glucocorticoid agonist in a orodispersible tablet formulation
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 [5].
Eosinophilic oesophagitis (new indication and formulation)
Oral

Further information

Yes
October 2019

Trial or other data

Dec 08: PIII BEE study (NCT00271349) completes. This study evaluated the efficacy and safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of 28 adult patients with active EE in Switzerland [2].

Evidence based evaluations

EPAR
NIHR

Budenofalk · Collagenous colitis - maintenance of remission in adults

Information

Budenofalk
Licence extension / variation
Dr Falk
Dr Falk

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
None

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].
Collagenous colitis - maintenance of remission 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

Jan 17. Phase 3 study (NCT01209208) completed [6].


Dec 15. Launched in UK for Collagenous Colitis, which is a distinct form of microscopic colitis. The current license does not cover lymphocytic colitis [4].


May 14: Will be filed via the EU Mutual Recognition procedure [3].

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

Trial or other data

May 16: NCT01209208 study still recruiting patients. Expected to complete collection of primary outcome data in December 2016 [5].


Nov 13: PIII NCT01209208 study continue to recruit pts [1].


Mar 12: PIII NCT00217022 study is closed early, because of low enrollment [1].


May 10: PIII (NCT01209208) study to compare budesonide and mesalazine in the treatment of lymphocytic colitis begins. 75 pts will be recruited in Germany. Primary outcome is rate of clinical remission. Study is expected to complete in April 15 (primary outcome data collection complete in Dec 14) [1].


Aug 07: PIII NCT00180050 study completes. Approx 40 pts were recruited in Germany to assess whether budesonide is effective in the treatment of lymphocytic colitis. Primary outcome was proportion of patients in clinical remission after 6 weeks [1].


Jun 03: PII/III (NCT00217022) study begins recruiting pts in the US to assess efficacy and safety of budesonide compared with placebo for the treatment of diarrhoea in lymphocytic colitis. Primary outcome is satisfactory control of diarrhea during at least 3 of the last 4 weeks [1].

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

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

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]

Eosinophilic oesophagitis

Information

New formulation
Shire
Shire

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes

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].
Eosinophilic oesophagitis
Oral