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Use of Aminosalicylates in Diarrhoea-Predominant Irritable Bowel Syndrome

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Use of Aminosalicylates in Diarrhoea-Predominant Irritable Bowel Syndrome (19) & (11) EP 2 361 620 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 31.08.2011 Bulletin 2011/35 A61K 31/166 (2006.01) A61K 31/606 (2006.01) A61P 1/00 (2006.01) A61P 1/06 (2006.01) (2006.01) (2006.01) (21) Application number: 11000447.0 A61P 1/12 A61P 1/14 (22) Date of filing: 04.02.2005 (84) Designated Contracting States: (74) Representative: Keen, Celia Mary AT BE BG CH CY CZ DE DK EE ES FI FR GB GR J.A. Kemp & Co. HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR 14 South Square Gray’s Inn (30) Priority: 06.02.2004 AU 2004900563 London WC1R 5JJ (GB) (62) Document number(s) of the earlier application(s) in Remarks: accordance with Art. 76 EPC: •This application was filed on 20-01-2011 as a 05700172.9 / 1 720 536 divisional application to the application mentioned under INID code 62. (71) Applicant: PHARMATEL (R&D) PTY LIMITED •Claims filed after the date of filing of the application/ as Trustee for the PHARMATEL (R & D) TRUST date of receipt of the divisional application (Rule 68 Hornsby, NSW 2077 (AU) (4) EPC). (72) Inventor: Shortis, Nicolas Peter Five Dock New South Wales 2046 (AU) (54) Use of aminosalicylates in diarrhoea-predominant irritable bowel syndrome (57) A method for the treatment ofprophylaxis of non- thereof together with a suitable carrier. Use of bal- inflammatory bowel diseases, diarrhoea- predominant ir- salazide, a 4-ASA or 5-ASA compound modified to in- ritable bowel syndrome or other non-specific bowel dis- clude a 4-ABA side chain, or a salt or derivative thereof, order is disclosed comprising administering to a patient for the manufacture of a medicament for the treatment in need of such treatment or prophylaxis an effective of prophylaxis of non-inflammatory bowel disease, diar- amount of balsalazide, or a 4-ASA or 5-ASA compound rhoea-predominant Irritable Bowel Syndrome or other modified to include a 4-ABA side chain, or a salt or a non-specific bowel disorder is also disclosed. derivative thereof, or a composition comprising bal- salazide the modified compound, or a salt or a derivative EP 2 361 620 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 361 620 A1 2 Description mation is absent and can only be detected by taking a biopsy and finding histological changes of inflammation. Technical Field In this case the pathologist terms the IBD as "microscopic colitis". [0001] This invention relates to the use of balsalazide 5 [0006] Where there are no visible colonoscopic or his- for treatment of Non-Inflammatory Bowel Disease for ex- tological abnormalities in the colon and when the stool ample diverticulosis/diverticulitis, diarrhoea-predomi- tests are negative for any known infection, and yet the nant Irritable Bowel Syndrome (IBS), or other non-spe- patient complains of symptoms referrable to the colon, cific bowel disorders such as Irritable Bowel Syndrome such as urgency, diarrhoea, flatulence, cramping the (IBS) at times alternating with constipation. 10 diagnosis of Irritable Bowel Syndrome can be made. Be- tween 5% and 25% of the western population in different Background of the Invention age groups may suffer from this disorder which has also been termed spastic colon, unstable colonic neurosis, [0002] Diarrhoea-predominant IBS is a condition spastic colitis or mucous colitis. In a classic case there known to arise from non-obvious causes. In particular, 15 is a triad of symptoms including low abdominal pain re- Irritable Bowel Syndrome which is defined as being a lieved by defecation, alternating constipation/diarrhoea non-inflammatory bowel disease is known not to be and the passage of small calibre stools. In some patients caused by any detectable infection by a pathogenic or- there may be accompanying watery diarrhoea with or ganism or organisms. without pain. Distension, flatulence, wind and at times [0003] Irritable Bowel Syndrome is therefore not a form 20 nausea and headaches may also be accompanying sys- of Inflammatory Bowel Disease. Inflammatory Bowel Dis- temic symptoms. At times diarrhoea alternates with con- eases are characterised by inflammation on histology stipation. and inflammation on colonoscopy whereas Irritable Bow- [0007] The pathogenesis of IBS is unclear. Emotional el Syndrome shows no evidence of inflammation on disturbances, fibre deficiency, purgative abuse and food colonoscopy and the histology shows no increase in in- 25 intolerancehave been some of the implicated aetiological flammatory cells. Irritable Bowel Syndrome is therefore agents but none have been proven nor well demonstrat- referred to as a "non specific" bowel disorder because ed. Evidence is therefore lacking for an infective cause there is no specific diagnostic criterion such as histology or auto-immunity. Conventional treatments for IBS have or a blood test that can diagnose it. Irritable Bowel Syn- been unsatisfactory as exemplified by the large number drome is only diagnosed when one excludes the pres- 30 of therapies that have from time to time been recom- ence of other "specific" diseases or disorders such as mended or trialed. These have included psychotherapy, Salmonella, Gastroenteritis, Campylobacter gastroen- dietary regimens, anti-spasm agents, anti-cholinergics, teritis, Clostridium difficile infection, Giardiasis, Crohn’s anti-depressants, bulking agents, various receptor an- disease or Ulcerative colitis. Irritable Bowel Syndrome tagonists, carminatives, opiates, and tranquillisers - all can be distinguished from infective and inflammatory35 without substantial success. Indeed there is no evidence bowel diseases such as colitis or Crohn’s disease on that cure is possible. Yet IBS is one of the most common culture or histological grounds and endoscopic appear- of all the gastrointestinal illnesses and though not life- ances. threatening, causes great distress especially to those se- [0004] Irritable Bowel Syndrome is therefore a collec- verely affected, and may bring a feeling of frustration and tion of symptoms such as bloating, diarrhoea, cramping, 40 helplessness, being generally lifelong. In particular, di- flatulence, or constipation where there is no specific di- arrhoea-predominant IBS can cause incontinence in agnostic test that turns it into a specific bowel disorder. some patients and, for example, the inability of being Irritable Bowel Syndrome may therefore be diagnosed sure that one can reach ones employment causing some by exclusion of other specific bowel disorders. Another to drive from rest room to rest room on their way to work. example of a non specific gastrointestinal disorder is non 45 In some patients urgency is so severe that they can only ulcer dyspepsia. hold their motions for a few seconds. [0005] The large bowel in man and to a lesser extent [0008] One treatment that has been proposed for the the small bowel, contain large concentrations of various treatment of IBS and for other bowel diseases is the use enteric bacteria. Generally, patients will have no pain, of certain classes of aminosalicylic acids. For example cramping, diarrhoea or constipation if the bacterial con- 50 Borody in US 5,519,014 describes the use of 5- aminosal- tents are not infected with pathogenic strains which may icylic acids (5- ASA compounds) for the treatment of IBS. colonise the bowel and remain there for prolonged peri- Similarly, Lin et al (US Patent 6,326,364) teaches that 5- ods of time. Acute infections and some chronic infections ASA compounds can inhibit clostridia (a pathogen). of the bowel flora however can cause inflammatory [0009] Whilst priorart methods go some way to treating changes in the lining. When inflammation is visible this 55 IBS, there is a need for other treatment regimes and in condition is called Inflammatory Bowel Disease (IBD), particular treatment regimes for non-specific bowel dis- which can be transient or long term for example ’ul- orders such as diarrhoea-predominant IBS which may cerative colitis’. In some forms of IBD the visible inflam- not be effectively treated by prior art methods. 2 3 EP 2 361 620 A1 4 Object of the Invention eases, diarrhoea-predominant Irritable Bowel Syndrome or other non-specific bowel disorder. [0010] It is an object of the present invention, at least in preferred embodiments to overcome or substantially Definitions ameliorate at least one of the above disadvantages or at 5 least provide a suitable alternative. [0018] The following definitions are intended as gen- eral definitions and should in no way limit the scope of Summary of the Invention the present invention to those terms alone, but are put forth for a better understanding of the following descrip- [0011] According to a first aspect, there is provided a 10 tion. method for the treatment or prophylaxis of non-inflam- [0019] Unless the context requires otherwise or spe- matory bowel diseases, diarrhoea-predominant irritable cifically stated to the contrary, integers, steps, or ele- bowel syndrome or other non-specific bowel disorder ments of the invention recited herein as singular integers, comprising administering to a patient in need of such steps or elements clearly encompass both singular and treatment or prophylaxis an effective amount of bal-15 plural forms of the recited integers, steps or elements. salazide or a salt or a derivative thereof or a composition [0020] Throughout this specification, unless the con- comprising balsalazide or a salt or a derivative thereof text requires otherwise, the word "comprise", or varia- together with a suitable carrier. tions such as "comprises" or "comprising", will be under- [0012] In one embodiment, in a sub-group of patients stood to imply the inclusion of a stated step or element the method alleviates symptoms of alternating diarrhoea 20 or integer or group of steps or elements or integers, but and constipation type Irritable Bowel Syndrome or con- not the exclusion of any other step or element or integer stipation-predominant Irritable Bowel Syndrome.
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