Once Daily Salofalk Granules Now Available In 1.5G Sachet For Ulcerative Colitis

Main Category: GastroIntestinal / Gastroenterology
Article Date: 14 Nov 2008 - 5:00 PDT

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Dr Falk Pharma has today launched Salofalk granules in a new 1.5g sachet. Treatment of active ulcerative colitis once daily is now even easier with the new sachet as it offers patients simpler dosing of one or two sachets a day.

A recent study, published in Gut, showed that 80% of patients preferred once daily dosing to three times daily, both of which are efficacious and safe. The study went on to recommend that where possible patients should be treated with a once-daily dosing regimen in order to enhance adherence.1

Adherence to therapy is particularly important for patients with ulcerative colitis as non-adherence increases the risk of relapse five-fold, increases disease morbidity, reduces quality of life and is associated with an increased risk of colorectal cancer.2 Despite this impact, 43% of patients with inflamatory bowel disease admit to taking less than 80% of their prescribed dose.3

Dr Andrew Robinson, Consultant Gastroenterologist, Hope Hospital, Salford comments: "The launch of the 1.5g sachet of Salofalk granules for ulcerative colitis should be welcomed by both clinicians and patients. Adherence amongst this patient population is particularly challenging despite adherence being essential to swift maintenance and long term control of the condition. The option of an oral, once-daily medication available in one to two sachets is an important treatment advance."

Ulcerative colitis (UC) is a chronic inflammatory and debilitating disease of the gastrointestinal tract characterised by flare-ups and remission phases.4 It is not known what causes the condition5and, as yet, there is no cure resulting in lifelong treatment for patients.

It affects up to 120,000 people in the UK and between 6,000 and 12,000 new cases are diagnosed each year.6 A patients' quality of life is significantly affected by abdominal pain, bloody diarrhoea and continual tiredness. UC can also cause inflammation in the eyes, skin and joints. 6

The launch of the 1.5g sachet extends Dr Falk's portfolio of products, which has been developed to meet patients' needs, such as making treatments easy to take. The 1.5g Salofalk granules offers all the benefits of prolonged, consistent release of the active ingredient mesalazine over the whole colon surface.7,8 This means the granules can be taken once a day in active ulcerative colitis9 with no loss of efficacy.1

Notes

Salofalk granules dosing guide

A once daily dose of 1.5 - 3g of mesalazine in acute ulcerative colitis (adult recommended dosage) Granules taken on the tongue and swallowed without chewing with plenty of liquid Small slow release granule with vanilla-flavoured lubricant outer layer Salofalk is the only mesalazine formulation licenced for the treatment of children above the age of 6

1. Kruis W, et al. Once-daily versus three-times-daily mesalazine granules in active ulcerative colitis: A double-blind, double-dummy, randomised non-inferiority trial Gut published online. October 2008i doi:10.1136/gut.2008.154302.

2. Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther 2006; 23: 577-85

3. Shale MJ, Riley SA. Studies of compliance with delayed release mesalazine therapy in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2003; 18: 191-8

4. Kane et al. Systematic Review: Adherence Issues in the Treatment of Ulcerative Colitis. Aliment Pharmacol Ther. 2006 Mar 1;23(5):577-85

5. Ardizzone S. Ulcerative colitis. Orphanet encyclopaedia. September 2003: http://www.orpha.net/data/patho/GB/uk-UC.pdf [Last accessed 25th January 2008]

6. NACC website: http://www.nacc.org.uk/content/ibd.asp [last accessed 28th October 2008)

7. Marakhouski Y et al. A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis. Aliment Pharmacol Ther 2005; 21: 133-40

8. Brunner M et al. Gastrointestinal transit and release of 5-aminosalicylic acid from 153Sm-labelled mesalazine pellets vs. tablets in male healthy volunteers. Aliment Pharmacol Ther 2003; 17: 1163-9

9. Salofalk Summary of Product Characteristics

http://www.falkfoundation.com

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