New Once Daily Salofalk Granules Launched For Ulcerative Colitis

Main Category: GastroIntestinal / Gastroenterology
Article Date: 07 Feb 2008 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Dr Falk Pharma launches once a day Salofalk granules, for the treatment of active ulcerative colitis.

The Salofalk granules are a step forward in the treatment of ulcerative colitis as they offer prolonged, consistent release of the active ingredient mesalazine over the whole colon surface.1,2 This means the granules can be taken once a day in active ulcerative colitis 3 with no loss of efficacy.4

Clinical trials have shown that 61% of patients who expressed a preference chose Salofalk granules over previous mesalazine tablet formulation.5 The new formulation is thought to be favoured due to the convenience of a once daily regimen and the vanilla-tasting granule coating which makes the granules more palatable.3 Additionally as the granules can be taken with or without food,1 patients are given the choice of when to take the treatment.

Ulcerative colitis (UC) is a chronic inflammatory and debilitating disease of the gastrointestinal tract characterised by flare-ups and remission phases.6 Symptoms are unpleasant including abdominal pain and diarrhoea, mixed with pus, blood, and mucus.7 It is not known what causes the condition8 and, as yet, there is no cure, therefore the patients' quality of life is significantly affected and lifelong treatment is required.

Professor Alastair Forbes at University College Hospital in London comments: "Flare-ups of ulcerative colitis are unpleasant and unpredictable. It is therefore important that treatments are convenient and efficacious. Adherence is an issue with many patients so the option of an oral, once-daily medication is an important treatment option.

In active ulcerative colitis, non-adherence increases disease morbidity, reduces quality of life and is associated with an increased risk of colorectal cancer.9 However despite this impact, 43% of patients with inflamatory bowel disease admit to taking less than 80% of their prescribed dose.10

Tony McFadyen, M.D. of Dr Falk Pharma in the UK says: "The strongest predictor of medication adherence, and therefore disease remission in ulcerative colitis patients is the number of daily doses.10,11 Dr Falk Pharma is pleased to launch Salofalk once daily granules which we hope will help with treatment adherence issues in addition to alleviating symptoms of active ulcerative colitis. The treatment adds to our portfolio of gastroenterology and hepatology treatments which includes Budenofalk Foam for ulcerative colitis, Budenofalk capsules for Crohn's Disease and Ursofalk for primary biliary cirrhosis".

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

References

1. 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

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

3. Salofalk Summary of Product Characteristics

4. Kruis W et al. Once daily dosing of 3g mesalamine (Salofalk Granules) is therapeutic equivalent to a three-times daily dosing of 1g mesalamine for the treatment of active ulcerative colitis. Gastroenterology 2007: 132; A-130 (898)

5. Kruis W et al. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine. Clin Gastroenterol Hepatol 2003; 1: 36-43

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

7. CORE Website. [last accessed 25th January 2008)

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

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

10. 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

11. Eisen SA et al. The effect of prescribed daily dose frequency on patient medication compliance. Arch Intern Med 1990; 150: 1881-84

Dr Falk Pharma