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(12) Patent Application Publication (10) Pub. No.: US 2009/0324736A1 Johnson Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2009/0324736A1 Johnson Et Al US 20090324736A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0324736A1 Johnson et al. (43) Pub. Date: Dec. 31, 2009 (54) METHODS OF TREATING BOWEL DISEASES (22) Filed: May 7, 2009 BY ADMINISTERING ABOWEL CLEANSER AND AN ANTIBOTC Related U.S. Application Data (60) Provisional application No. 61/051,341, filed on May (75) Inventors: Lorin Johnson, Palo Alto, CA 7, 2008. (US); William Forbes, Raleigh, NC (US); Stephana Patton, San Publication Classification Francisco, CA (US) (51) Int. Cl. Correspondence Address: A633/42 (2006.01) EDWARDS ANGELL PALMER & DODGE LLP A633/14 (2006.01) P.O. BOX SS874 A63L/439 (2006.01) BOSTON, MA 02205 (US) (52) U.S. Cl. .......................... 424/606: 424/679:514/279 (57) ABSTRACT (73) Assignee: Salix Pharmaceuticals, Ltd., Morrisville, NC (US) The present invention relates to formulations and kits for the treatment of bowel disease, to their use in medicinal prepa (21) Appl. No.: 12/437,232 rations and to therapeutic methods thereof. US 2009/032473.6 A1 Dec. 31, 2009 METHODS OF TREATING BOWEL DISEASES 0009. According to one embodiment, the GI cleanser BY ADMINISTERING ABOWEL CLEANSER comprises one or more of a PEG based composition or a AND AN ANTIBOTC Sodium phosphate based composition. 0010. According to one embodiment, the GI cleanser RELATED APPLICATIONS comprises polyethylene glycol (PEG), sodium sulfate, 0001. This application claims the benefit of U.S. Provi Sodium chloride, potassium chloride, and ascorbic acid. sional Application No. 61/051,341, filed May 7, 2008, the 0011. According to one embodiment, the GI cleanser is entire contents of which is expressly incorporated herein by supplied as two pouch A's comprising 100 grams of PEG reference. 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride; and two BACKGROUND pouch B’s comprising 4.7 grams of ascorbic acid, and 5.9 grams of sodium ascorbate. 0002 Rifaximin (INN; see The Merck Index, XIII Ed., 8304) is an antibiotic belonging to the rifamycin class of 0012. According to one embodiment, the GI cleanser antibiotics, e.g., a pyrido-imidazo rifamycin. Rifaximin comprises 32 or 40 tablets comprising sodium phosphate exerts its broad antibacterial activity, for example, in the monobasic, sodium phosphate dibasic, PEG 8000, and mag gastrointestinal tract against localized gastrointestinal bacte nesium sterate. ria that cause infectious diarrhea, irritable bowel syndrome, 0013. According to one embodiment, the GI cleanser Small intestinal bacterial overgrowth, Crohn's disease, and/or comprises sodium phosphate monobasic, sodium phosphate pancreatic insufficiency. It has been reported that rifaximinis dibasic, microcrystalline cellulose, colodial silicon dioxide, characterized by a negligible systemic absorption, due to its and magnesium sterate. chemical and physical characteristics (Descombe J. J. et al. 0014. According to one embodiment, the GI cleanser Pharmacokinetic study of rifaximin after oral administration comprises Fleet(R) Phospho-soda?R EZ-Prep; miral AX: a in healthy volunteers. Int J Clin Pharmacol Res, 14 (2), bulk producing purgative; a serotonin agonist; a hyperos 51-56, (1994)). motic agent; GoLytely; Glycolax; Colyte; or NuLytely. 0003 Rifaximin is described in Italian Patent IT 1154655 These purgatives are described more fully below. and EP 0161534, both of which are incorporated herein by 0015. According to one embodiment, the method further reference in their entirety for all purposes. U.S. Pat. No. comprises administering an antibiotic prior to the administra 7,045,620 B1 discloses polymorphic forms of rifaximin. tion of the gastrointestinal cleanser. In another embodiment, 0004 Rifaximin is approved for the treatment of patholo the antibiotic is administered with the GI cleanser, between gies caused by non-invasive strains as Escherichia coli, the administration of the GI cleanser and the antibiotic, and/or micro-organism which are not able to penetrate into GI prior to the GI cleanser. If this antibiotic is different from the mucosa and they remain in contact with the GI fluids. antibiotic given after the GI cleanser, then the antibiotic may also, in accordance with another embodiment, be adminis SUMMARY tered with the antibiotic that is administered after the GI cleanser. 0005 Disclosed herein are methods of preventing, ame 0016. According to one embodiment, the methods may liorating and/or treating one or more bowel diseases (BDS). In further comprise administering an antibiotic with the admin general, subjects who may benefit from the treatment with a istration of the gastrointestinal cleanser. GI cleanser and rifaximin include those who are susceptible 0017. According to one embodiment, the methods may to BDs, those who have active or acute diseases and those who further comprise performing a colonoscopy on the Subject are in remission from one or more BD. BDs include, for example, irritable bowel syndrome, Crohn's disease, travel after the administration of the gastrointestinal cleanser. er's diarrhea, ulcerative colitis, enteritis, Small intestinal bac 0018. According to one embodiment, the administration terial overgrowth, chronic pancreatitis, pancreatic insuffi of the gastrointestinal cleanser is within between about 1 to ciency, pouchitis, diverticulitis, colitis or hepatic about 90 days before the administration of the antibiotic. encephalopathy. Subjects who may particularly benefit from 0019. According to one embodiment, the administration this treatment include those who have mild to moderate IBS. of the gastrointestinal cleanser is within between about 1 to 0006. According to one aspect, provided herein are meth about 60 days; between about 1 to about 30 days; between ods of treating bowel disease (BD), comprising administering about 1 to about 24 days; between about 1 to about 14 days: a gastrointestinal cleanser (GI) to a subject in need thereof, between about 1 to about 10 days; between about 1 to about 7 and administering a therapeutically effective amount of an days; between about 1 to about 5 days; between about 1 to antibiotic. about 4 days; between about 1 to about 3 days; or between 0007 According to one embodiment, the administering of about 1 to about 2 days before the administration of the the GI cleanser and the antibiotic results in from between antibiotic. about 35-70% of subjects with adequate relief of one or more 0020. According to one embodiment, one or more of an of IBS symptoms, abdominal pain symptoms, or bloating anti-inflammatory, one or more additional antibiotics, cro symptoms. felemer, or metoclopramide is administered to the Subject. 0008 According to one embodiment, the antibiotic com The administration of these compositions may be prior to the prises one or more of a rifamycin, aminoglycoside, ampheni GI cleanser, with the GI cleanser, between the GI cleanserand col, ansamycin, B-Lactam, carbapenem, cephalosporin, the antibiotic, with the antibiotic and/or after the antibiotic. cephamycin, monobactam, oxacephem, lincosamide, mac 0021. According to one embodiment, the methods may rolide, polypeptide, tetracycline, or a 2,4-diaminopyrimidine further comprise selecting Subjects who respond to treatment class antibiotic. after being treated for between about 1 and about 52 weeks or US 2009/032473.6 A1 Dec. 31, 2009 longer; and removing a responding Subject from treatment colonoscopy prior to a therapeutically effective amount of the wherein after removal of treatment there is a durability of antibiotic results in from between about 35-70% of subjects response. with adequate relief of one or more of IBS symptoms, 0022. According to one embodiment, the subject is treated abdominal pain symptoms, or bloating symptoms. for between about 1 and about 24 weeks with the antibiotic 0036. According to one aspect, provided herein are thera administered after the GI cleanser. peutics comprising a gastrointestinal (GI) cleanser and a 0023. According to one embodiment, the bowel disease therapeutically effective amount of an antibiotic. comprises, one or more of inflammatory bowel disease (IBD), 0037 According to one embodiment, the therapeutically Crohn's disease, hepatic encephalopathy, enteritis, colitis, effective amount of the antibiotic comprises from between irritable bowel syndrome (IBS), fibromyalgia (FM), chronic about 100 mg and about 6000 mg; from between about 50 mg fatigue syndrome (CFS), depression, attention deficit/hyper and about 2500 mg BID; from between about 50 mg and activity disorder (ADHD), multiple sclerosis (MS), systemic about 2000 mg TID: 550 mg TID: 550 mg BID; 600 mg TID: lupus erythematosus (SLE), travelers’ diarrhea, small intesti 600 mg BID: 1650 mg. nal bacterial overgrowth, chronic pancreatitis, or pancreatic 0038. In one embodiment, the therapeutically effective insufficiency. amount of the antibiotic comprises from between about 100 0024. According to one embodiment, hepatic encephal mg and about 6000 mg. opathy subject will be administered the antibiotic (e.g., rifaxi 0039. In one embodiment, the therapeutically effective min) for between about 24 weeks and 24 months or longer. amount of the antibiotic comprises 550 mg TID. 0025. According to one embodiment, the therapeutically 0040. In one embodiment, the therapeutically effective effective amount of the antibiotic comprises from between amount of the antibiotic comprises 550 mg BID. about 100 mg and about 6000 mg; from between about 50 mg 0041. In one embodiment, the therapeutically effective and about
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