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(12) United States Patent (10) Patent No.: US 7,608,625 B2 Miyawaki Et Al

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(12) United States Patent (10) Patent No.: US 7,608,625 B2 Miyawaki Et Al USOO7608625B2 (12) United States Patent (10) Patent No.: US 7,608,625 B2 Miyawaki et al. (45) Date of Patent: Oct. 27, 2009 (54) METHOD FORTREATING BRUXISMAND Chase et al., Mental Health Aspects of Developmental Disabilities, BRUXISM-RELATED DISEASES (2002), 5(2), pp. 34-45.* Rogers et al., Am. J. Ment. Retardation, (Mar. 1992), 96(5):522-7 (75) Inventors: Shouichi Miyawaki, Kagoshima (JP); (abstract).* Teruko Yamamoto, Okayama (JP) Shaw et al., ASDC J. Dent. Child. 65(6), (Nov.-Dec. 1998), pp. 484-486. (73) Assignee: Eisai R & D Management Co., Ltd., Bell et al., Aust. Dent. J., 47(1), (Mar. 2002), pp. 30-35.* Tokyo (JP) Abstract of Katayama, A., et al., “Effect of Gastric-Acid-Inhibiting Drugs on Rhythmic Masticatory Muscle Activity.” presented at the 82"General Session and Exhibition of the IADR, accessible online at (*) Notice: Subject to any disclaimer, the term of this http://iadr, confex.com/iadr/2004Hawaii/techprogram? patent is extended or adjusted under 35 abstract 44719.htm on Nov. 27, 2003. U.S.C. 154(b) by 0 days. Lavigne G.J. Manzini, C., “Bruxism” In: Kryger MH, Roth T. Dement WC, editors. Principles and Practice of Sleep Medicine. (21) Appl. No.: 10/547,796 Philadelphia: W.B. Saunders, 2000, 773-785. LobbeZoo, F., et al., “The Effect of the Catecholamine Precursor (22) PCT Filed: Jan. 30, 2004 L-Dopa on Sleep Bruxism: A Controlled Clinical Trial.” Movement Disorders 12:73-78, Movement Disorder Society (1997). (86). PCT No.: PCT/UP2004/000939 Miyawaki, S., et al., “Association Between Nocturnal Bruxism and Gastroesophageal Reflux.” Sleep 26:888-892, Associated Profes S371 (c)(1), sional Sleep Societies, LLC (Nov. 2003). (2), (4) Date: Sep. 6, 2005 Patent Abstracts of Japan, English language abstract for JP 01-290628 A, (1989). (87) PCT Pub. No.: WO2004/080487 Patent Abstracts of Japan, English language abstract for JP 02-022225A, (1990). PCT Pub. Date: Sep. 23, 2004 The Merck Manual, 17' Edition, Merck Research Laboratories, Chapter 20, pp. 232-233 (1999). (65) Prior Publication Data Miyawaki, S., et al., “Association between nocturnal bruxism and US 2006/O173O45A1 Aug. 3, 2006 gastroesophageal reflux.” presented at 81 General Session of the IADR, Sweden, 4 pages (Jun. 27, 2003). (30) Foreign Application Priority Data Abstract published in J. Dent. Res. 82: B-296. Abstract No. 2284. International and American Associations for Dental Research (Jun. Mar. 13, 2003 (JP) ............................. 2003-068755 2003; published online Feb. 25, 2003). Becht, J.L. and T.D. Byars, “Gastroduodenal ulceration in foals," (51) Int. Cl. Equine Vet J., 18: 307-12. Equine Veterinary Journal Ltd, Cambs, A6 IK 3/44 (2006.01) UK, (July 1986). A6 IK 3/425 (2006.01) Cuypers, J. et al., “Therapy of cluster headache with histamine HI (52) U.S. Cl. ....................................... 514/292; 514/370 and H2 receptor antagonists," Eur Neurol: 18:345-7. S. Karger AG, Basel (Jan. 1979). (58) Field of Classification Search ................. 514/292, Dieckmann, M. And E. Deegen, "Magenulzera beim 514/370 Pferd klinische undgastroskopische Befunde bei 12 Pferden (1989 See application file for complete search history. 1990)' "Stomach ulcers in the horse—clinical and gastroscopic (56) References Cited findings in 12 horses (1989-1990) . Tierarztl Prax: 19(4): 386-394, Schattauer, (Aug. 1991). U.S. PATENT DOCUMENTS E.L. Spierings, “Headache of gastrointestinal Origin. case studies.” Headache: 42(3): 217-9, Wiley InterScience (Mar. 2002). 4.255.431 A 3/1981 Junggren et al. 4,628,098 A 12/1986 Nohara et al. (Continued) 4,758,579 A 7, 1988 Kohl et al. 4,808,596 A 2f1989 Matsuishi et al. Primary Examiner Frederick Krass 5,045,552 A 9, 1991 Souda et al. Assistant Examiner Sara E Clark 5,840,910 A 11/1998 Souda et al. (74) Attorney, Agent, or Firm—Sterne, Kessler, Goldstein & 5,916,904 A 6, 1999 Sato et al. Fox P.L.L.C. 5.948,789 A 9, 1999 Larsson et al. 5.998.445 A 12/1999 Souda et al. (57) ABSTRACT 6,063,782 A 5, 2000 Kimura et al. 6.426,369 B1 7/2002 Sato et al. 6,740,667 B2 5, 2004 Sato et al. The present invention provides a preventive or therapeutic agent for bruxism or bruxism-related diseases that contains as FOREIGN PATENT DOCUMENTS an active ingredient at least one selected from the group WO WO94,28923 A1 12, 1994 consisting of proton pump inhibitors, histamine H2 receptor WO WOO1? 62290 A2 8, 2001 antagonists, and acid pump antagonists. Examples of the proton pump inhibitors include rabeprazole, omeprazole, OTHER PUBLICATIONS esomeprazole, lanSoprazole, pantoprazole, or tenatoprazole, Bartlett et al., Drugs of Today (1998), 34(3): 231-239.* or salts thereof, or hydrates thereof. Cross et al., Annals of Pharmacotherapy, (May, 2002) 36(5), pp. 912-916. 6 Claims, 3 Drawing Sheets US 7,608.625 B2 Page 2 OTHER PUBLICATIONS Partial English translation of document NPL 16: K. Taniyama, from Chapter 9 of “New Pharmacodynamics revised fourth edition.” C. Tanaka and R. Kato., eds., Nankodo Co., Ltd., Tokyo, Japan, pub K. Taniyama, from Chapter 9 of “New Pharmacodynamics revised lishers, pp. 452-454 (2002). fourth edition. C. Tanaka and R. Kato., eds., Nankodo Co., Ltd., Tokyo, Japan, publishers, pp. 452-454 (2002). * cited by examiner U.S. Patent Oct. 27, 2009 Sheet 1 of 3 US 7.608,625 B2 FIG.1 O 5 1 O 15 2O 25 3O 35 ag ) MN. DECREASEDESOPHAGEAL pH EPISODE g100(%) 8O d 6O 40 ass: 2O SL 19O vow wroverwrongeronm H O 5 1 O 15 2O 25 3O 35 40 U.S. Patent Oct. 27, 2009 Sheet 2 of 3 US 7,608,625 B2 FIG.2 PLACEBO MEDCATION PPIMEDICATION 1:30 2:00 4:OO 4:30 5:00 4:00 4:30 SOO ELAPSED TIME (HOUR) 1 OO 9 O . --- Sa Lu 8 32 8O S. 7 E 70 6 s 2. 6O Sg 5 M 5O 5 4 55 40 Lil Za 925 3 9 30 5, 2 5, 20 SA 1 1O O PLACEBO PP O PLACEBO PP MEDICATION MEDICATION MEDCATION MEDICATION U.S. Patent Oct. 27, 2009 Sheet 3 of 3 US 7,608,625 B2 FIG.3 EGIOSIdEWSIXT:Hº-IOKONETTÒBH+(HñOH/SHWII) PP--H2RA US 7,608,625 B2 1. 2 METHOD FOR TREATING BRUXISMAND Thus, the present invention provides: BRUXISM-RELATED DISEASES (1) a preventive or therapeutic agent for bruxism compris ing an inhibitor of gastric acid secretion as an active ingredi This application is a 35 U.S.C. 371 (national stage) appli ent; cation of PCT/JP04/00939, filed Jan. 30, 2004. (2) a preventive or therapeutic agent for bruxism compris ing at least one selected from the group consisting of a proton TECHNICAL FIELD pump inhibitor, a histamine H receptor antagonist, oran acid pump antagonist as an active ingredient; The present invention relates to a preventive ortherapeutic (3) a preventive or therapeutic agent for bruxism compris agent for bruxism, and more particularly to a preventive or 10 ing a proton pump inhibitor and a histamine H2 receptor therapeutic agent for bruxism and bruxism-related diseases antagonist as an active ingredient; that contains a drug that Suppresses gastroesophageal reflux (4) a preventive or therapeutic agent for bruxism compris ing a proton pump inhibitor as an active ingredient; as an active ingredient. (5) the preventive ortherapeutic agent according to any one 15 of (2) to (4), wherein the proton pump inhibitor is rabepra BACKGROUND ART Zole, omeprazole, esomeprazole, lanSoprazole, pantoprazole or tenatoprazole, or a salt of the foregoing, or hydrate of the Bruxism is thought to involve parafunction, abnormal oral foregoing: habit or parasomnia. Bruxism can have a serious effect on (6) the preventive ortherapeutic agent according to any one health, as it causes such conditions as dental attrition and of (2) to (4), wherein the proton pump inhibitor is rabeprazole tooth fracture, pain and discomfort in masticatory muscle, or a salt thereof; and temporomandibular disorders. (7) the preventive ortherapeutic agent according to any one Although occlusion was previously thought to be involved of (2) to (4), wherein the proton pump inhibitor is a sodium in the onset of bruxism, it has recently become clear that salt of rabeprazole; occlusion is hardly involved at all in the onset of this condi 25 (7-1) the preventive or therapeutic agent according to any tion (for example, see the non-patent reference 1). one of (2) to (4), wherein the proton pump inhibitor is ome To date, treatment for bruxism has only involved such prazole or a salt thereof; splint (Nightguard) therapy as insertion of a splint similar to (7-2) the preventive or therapeutic agent according to any a boxing mouthpiece that prevents the upper and lower teeth one of (2) to (4), wherein the proton pump inhibitor is esome from touching, cognitive behavioral therapy to train the indi 30 prazole or a salt thereof; vidual to consciously prevent the involuntary movements, (7-3) the preventive or therapeutic agent according to one biofeedback therapies, and pharmacotherapies. Of these, the of (2) to (4), wherein the proton pump inhibitor is lansopra splint therapy is extremely expensive and questionable in Zole; terms of its effectiveness. With pharmacotherapies, there (7-4) the preventive or therapeutic agent according to any have been reports that an anxiolytic agent such as diazepam, 35 one of (2) to (4), wherein the proton pump inhibitor is pan a tricylic antidepressant, a muscle relaxant, and L-dopa are toprazole or a salt thereof; effective as a preventive ortherapeutic agent for bruxism (for (8) the preventive or therapeutic agent according to (2) or example, see non-patent reference 2).
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